zirconia / color / pmma / wax sagemax · : the highest strength dental zirconia. 1500 mpa. it has...

The Fusion of Superior TechnologiesZ I R C O N I A C O L O R P M M A W A X/ / /

www.sagemax.com sagemax®

Stained by

Coping Made of S

p 4-Point bending strength > 1,500 MPa (ISO 13356:2008)

p Biaxial flexural strength > 1,400 MPa (ISO 13356:2008)

p 1-CR (%) Translucency: >30% (Thickness: 1.0mm)

Zr Powered by Quality

S : Highest Strength Dental Zirconia

TM

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Table of Contents

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About Sagemax 04

Made in USA 05

Materials 06

Clinical Study (�e DENTAL ADVISOR Report) 07

Quality Management System Certifications (CE Mark, ISO 13485, 9001) 08

FDA 510K & IDENT Ceram 09

About NexxZr T -�e Highest Translucency Dental Zirconia 10

About NexxZr S -�e Highest Strength Dental Zirconia 11

About SagePMMA 12

About SageWAX 13

About NexxZr COLOR 14

NexxZr Capability 15

Shapes and Sizes 16

W-98 Disc Product List 17

R-99 Disc Product List 25

Z-95 Disc Product List 33

A-71 Disc Product List

D-98 Disc Product List 49

S-Blank Product List 57

K-Blank Product List 59

Contact 61

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About Sagemax

Our Neighbors

Sagemax Headquarters and Manufacturing Facility - 20,000 SF. Federal Way, WA, USA

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Based in the USA, Sagemax Bioceramics, Inc. is one of the largest manufacturers of dental zirconia in the world. Since our start in 2006, our customers have fabricated approximately 9 million zirconia restorations worldwide.

Using the highest quality machines and zirconia powder, our production combines German engineering with processes from Japan to produce consistent high quality zirconia blanks. Sagemax zirconia is carefully monitored throughout production andour quality system ensures our product is inspected for perfection.

After moving into a new facility in 2012, we are now capable of producing over 15,000discs per month and we are still expanding. �e Sagemax network reaches worldwide. We have branch offices in Italy, Germany, Netherlands, Russia and Hong Kong.

We have obtained international certifications such as CE mark, FDA 510K and the highest level certification for medical devices, ISO 13485.

of Seattle, Washington, USA.�ere are many great companies based in the surrounding neighborhoods

Page Title

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Made in USA

FAt the Sagemax USA manufacturingfacility we perform the followingprocesses:

Pre-form Zirconia Powder. Cold Isostatic Pressing. Uniaxial Pressing. Cutting and Milling. Firing for Pre-sintering. Shrinkage Analysis & Quality Control. Quality Testing Packaging Foam Cutting. Packing, Labeling and Shipping. Customer Service and Training.

cleared for use by the FDA as a medical device.

• High translucency ,non-shaded used for full contour and layering.

• High translucency, pre-shaded used for copings and hybrid layering.

• Color pastes for pre-staining green state zirconia.

• High strength, non-shaded used for polychromatic layering of copings, bridges, and implant substructures.

• PMMA discs used to produce temporaries, available in various shades as well as white and clear.

• Machinable wax, blue used for full contour and copings, white for diagnostic presentations.

T

S

Materials

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Results at 6 MonthsIn December, 2012, 25 NexxZr T restorations were recalled and evaluated.

recalled NexxZr TTM restorations were evaluated in the following categories

• Lack of sensitivity• Esthetics• Resistance to fracture/chipping• Resistance to marginal discoloration• Wear resistance of zirconia and opposing dentition• Retention

TM

Sagemax NexxZr T earned an excellent 5 star rating from �e Dental Advisor during a 6 month clinical evaluation. Independent In Vivo studies of 160 NexxZr T full contour restorations showed excellent results in all categories

Lack of sensitivity

Esthetics Resistance to Fracture/

Chipping

Wear Resistance

Retention Resistance to Marginal

Discolor ation

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0

4.7 4.85

4.85 5

Ratings of NexxZr T at 6-month recall.

Esthetics, resistance to fracture or chipping, resistance to marginal discoloration,and wear resistance of the resoration and opposing dentition rated excellent.

Clinical Study

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Quality Management System Cerifications

ISO 13485 ISO 9001 CE Mark

QUALITY MANAGEMENT SYSTEM - ISO 13485: 2003

This is to certify that:

Sagemax Bioceramics Inc34210 9th Avenue SouthSuite 118Federal WayWashington98003USA

Holds Certificate No: FM 550637and operates a Quality Management System which complies with the requirements of ISO 13485: 2003 for the followingscope:

Manufacturing and distributing of Sagemax Zr Dental zirconia blanks.Manufacturing and distributing of Sagemax Zr Dental zirconia blanks.

For and on behalf of BSI:

VP Regulatory Affairs, BSI Group America Inc.

Originally Registered: 12/20/2010 Effective Date: 06/28/2012 Expiry Date: 12/19/2013

Page: 1 of 1

This certificate remains the property of BSI and shall be returned immediately upon request.An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectoryTo be read in conjunction with the scope above or the attached appendix.Americas Headquarters: BSI Group America Inc., 12110 Sunset Hills Road, Suite 200, Reston, VA 20190, USA.A Member of the BSI Group of Companies.

QUALITY MANAGEMENT SYSTEM - ISO 9001:2008

This is to certify that:

Sagemax Bioceramics Inc34210 9th Avenue SouthSuite 118Federal WayWashington98003USA

Holds Certificate No: FM 550638and operates a Quality Management System which complies with the requirements of ISO 9001:2008 for the following scope:

Manufacturing and distributing of Sagemax Zr Dental zirconia blanks.Manufacturing and distributing of Sagemax Zr Dental zirconia blanks.

For and on behalf of BSI:

Gary Fenton, Global Assurance Director

Originally Registered: 12/20/2010 Latest Issue: 06/28/2012 Expiry Date: 12/19/2013

Page: 1 of 1

This certificate remains the property of BSI and shall be returned immediately upon request.An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectoryTo be read in conjunction with the scope above or the attached appendix.Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A Member of the BSI Group of Companies.

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Quality System Control

LAB COPY

The manu factur er certifies that the ce ramic materialprov ided to the laboratory with this ce rtificat e is FDA-listed Yttrium Zirconia.The laboratory ce rtifies that th e speci fied manufactur er,mater ials, systems, and proc edur es were used tofabricate this prosthesis.

DENTIST CERTIFICATE (attach t o patient recor d)

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672

www.identalloy.org

Material / Composition

CERAM

DIVIS ION OF THE IDENTALLOY COUNC IL

YTTRIUMZIRCO NIA

YZYZ

CERAM

DIVI SION OF THE IDENTALLOY CO UNCIL

YT TRIUMZ IRCON IA

YZYZ

Material / System Manufacturer


Material /System Manufacturer

LAB COPY

SAGEMAX NexxZr S SAGEMAX NexxZr S

SAGEMAX NexxZr SZirconium Oxide (Z rO2 + HfO2) 94%Ytt rium Oxide (Y 2O3) 5%Aluminum Oxide (Al 2O3) <1%Other Oxides <1%

SAGEMAX NexxZr SZirconiumOxide (Z rO2 + HfO2) 94%Yttrium Oxide (Y 2O3) 5%Aluminum Oxide (Al 2O3) <1%Other Oxides <1%

®®

®

®

LAB COPY

The manu factur er certifies that the ce ramic materialprov ided to the laboratory with this ce rtificat e is FDA-listed Yttrium Zirconia.The laboratory ce rtifies that th e speci fied manufactur er,mater ials, systems, and proc edur es were used tofabricate this prosthesis.

DENTIST CERTIFICATE (attach t o patient recor d)

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401

www.identalloy.org


CERAM

DIVIS ION OF THE IDENTALLOY COUNC IL

YTTRIUMZIRCO NIA

YZYZ

CERAM

DIVI SION OF THE IDENTALLOY CO UNCIL

YT TRIUMZ IRCON IA

YZYZ

Material / System Manufacturer


Material /System Manufacturer

LAB COPY

SAGEMAX NexxZr T SAGEMAX NexxZr T

SAGEMAX NexxZr TZirconium Oxide (Z rO2 + HfO2) 94%Ytt rium Oxide (Y 2O3) 5%Aluminum Oxide (Al 2O3) <1%Other Oxides <1%

SAGEMAX NexxZr TZirconiumOxide (Z rO2 + HfO2) 94%Yttrium Oxide (Y 2O3) 5%Aluminum Oxide (Al 2O3) <1%Other Oxides <1%

®®

®

®Maintaining a Quality System in theproduction of a medical device isnot only mandatory but critical to the success of the product. Traceability of the materials and production control are mandated bylaws and standards set by the “Federal Drug Administration” (FDA) under the classification of a“medical device”. Maintaining the quality standards requires a strongrelationship between Federalguidelines, material testing, production management and document control. �e Quality System reviews are carried out by regular intervals by regulatory agencies such as FDA, and independent auditors representing vendors. An external auditor qualifies our operation and internal auditors examine our system for improvements. All these system controls are designedto benefit our customers.

Property Unit NexxZrTM T Value Requirement for ISO

Bulk density g/cm3 6.085 ~6.095 ≥ 6.00 (ISO 13356:2008)

Chemical composi on: ZrO2 + HfO2 + Y2O3 > 99.5 > 99

ZrO2 91.6 N/AY2O3 5 4.5 to 6HfO2 3 ≤ 5Al2O3 < 0.15 < 0.5

Other oxides* < 0.2 < 0.5Microstructure:

Mean linear intercept distance

Biaxial Flexure Strength Mpa 1,150 ± 50 ≥ 500

CTE 10 x 10-6 (25~900°C) No ISO

Fracture Toughness: Mpa M½ 10 No ISO

Radioac vity: Bq/g 0.08 0.2 (ISO 13356:2008)

Final Sintered Hardness: HV10 1,200~1,300 No ISO

Pre-Sintered Blank Hardness: HV10 60~70 No ISO

Translucency: 1-CR% (1.0mm) > 34 No ISO

Percent Mass Frac on

0.25±0.05µm ≤ 0.4 (ISO 13356:2008)

Sagemax manufactures an incomparable translucent zirconia. Comparative testing shows NexxZr T as having the highest translucent properties of all materials tested. By the use of special formulas, isostatic pressing and precise sinter control,

results.

• Highest translucency • Lifelike esthetics • Perfect �ts • Excellent machinability • Absolute biocompatibility • Multi-unit capability

Indications: • Full contour polished • Full contour stained and glazed • Copings with polychromatic layering • Bridges with polychromatic layering • Hybrid restorations combining occlusal strength and esthetics

Proporties: • • 35% 1-CR translucent factor 1mm • 50% total transmittance at .60mm

Translucency (1-CR) tested by Color i7

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: The Highest Translucency Zirconia.T

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: The Highest Strength Dental Zirconia.

1500 Mpa. It has multiple uses, as lab technicians can create beautiful dental restorations by veneering porcelains over this material. NexxZr S represents the

• Absolute biocompatibility • Perfect �ts • Excellent machinability • Complete versatility • High strength

Indications: • Single crown copings with polychromatic layering • Long span bridges - full arch bridges • Implant substructures – abutments where high strength is required • Hybrid bridges - in combination with implants

S

Property Unit NexxZrTM S Value Requirement for ISO

Bulk density g/cm3 6.085 ~6.095 ≥ 6.00 (ISO 13356:2008)

Chemical composi on: ZrO2 + HfO2 + Y2O3 > 99.5 > 99

ZrO2 91.6 N/AY2O3 5 4.5 to 6HfO2 3 ≤ 5Al2O3 < 0.3 < 0.5

Other oxides* < 0.2 < 0.5Microstructure:

Mean linear intercept distance

Biaxial Flexure Strength Mpa 1,550 ± 50 ≥ 500

CTE 10 x 10-6 (25~900°C) No ISO

Fracture Toughness: Mpa M½ 10 No ISO

Radioac vity: Bq/g 0.1 0.2 (ISO 13356:2008)

Final Sintered Hardness: HV10 1,200~1,300 No ISO

Pre-Sintered Blank Hardness: HV10 65~80 No ISO

Translucency: 1-CR% (1.0mm) > 30 No ISO

Percent Mass Frac on

µm 0.25±0.05 ≤ 0.4 (ISO 13356:2008)

Strength Testing

Sagemax NexxZr S is the highest strength zirconia with a biaxial �exure strength of

PMMA-poly methyl methacrylate is our transparent thermoplastic material often used as an alternative to glass ceramics. It is primarily designed for production of long or short term temporary restorations.

Available in various shades, this material serves well for clinical as well as laboratory needs.

Available Colors: • Clear • White • Pre-shaded º A1, A2, A3, A4, B/C

Property Unit SagePMMA Value

Tensile Strength MPa > 75

Biaxial Flexure Strength MPa > 120

Elongation % 3

Refractive Index - 1.49

Water Absorption µg/mm3 0.3~0.4%

Composition Polymethyl Methacrylate

Bene�ts: • Absolute biocompatibility • Perfect fits • Excellent machinability • Strength and stability • High luster polishability • Stainable

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designs.

of acrylic allows the user to cast directly.

Available Colors:

Indications

• Cast copings

• Full contour cast

• Burnout and press over zirconia

• All burnout and cast needs

• Pressing and Over Pressing

� Blue Wax

Esthetically pleasing for diagnostic

presentations, these waxes are designed

to alleviate the high production cost

associated with manual hand waxing techniques.

Indications

• Diagnostic presentations

• Burn out and cast

� White Wax

• Burns out clean • Leaves no residue • Ash free • Easy machinability • Low coe�cient of thermal expansion • Excellent �t after cost

Property Unit SageWAX Value

Hardness Mpa > 53

Flexibility High > 45

Drop mel ng point °C 105~135

Flash point °C 300

Water Absorp on µg/mm3 Insoluble

Composi on Poly Wax

Sagemax wax discs are a blend of wax and acrylic, merging the best qualities ofeach. The ease of machinability of wax combined with the higher melting point

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Sagemax has developed a unique prestain paste for use with NexxZr T and NexxZr S. It is possible to achieve good color matches with maximum saturation in ten to twenty seconds. All 16 Vita shades are available and since these color pastes are alcohol based, it is a predictable and safe method.

Fully sintered NexxZr T and NexxZr S can be shaded externally with any reputable stain and glaze. Users of Sagemax color pastes will experience substantial savings in time and cost.

NexxZr Capability

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Clinical tests have revealed excellent results in patients with Sagemax restorations. Clinicians as well as patients experi-ence a great deal of satisfaction with the various choices of restorations that can be created with relative ease. Complete instructions and training are available from Sagemax. All the above mentioned types of restorations can yield exceptional results. �e various types are dependent on the speci�c requirements evaluated by the clinicians and the dental laboratories.

Sagemax NexxZr T and NexxZr S o�er great esthetics, strength, and versatility. Its translucent levels are the highest of all zirconia tested. Several types of restorations can be fabricated with Sagemax zirconia, all with exceptional results. �e user now has a choice to create restorations to whatever level of esthetics they desire.

It is possible to fabricate at least 5 di�erent types of restorations using NexxZr.

1. Prestained, sintered and polished (TP)

2. Prestained, sintered, and externally stained (TG)

3. Hybrid type, with minimum cutback and layering for esthetics (TH)

4. Prestained coping for polychromatic layering using NexxZr T (TL)

5. Prestained coping for polychromatic layering using NexxZr S (SL)

C E R T I F I E D

C R O W N • B R I D G ETP

C E R T I F I E D

C R O W N • B R I D G ETG

C E R T I F I E D

C R O W N • B R I D G ETH

C E R T I F I E D

C R O W N • B R I D G ETL

C E R T I F I E D

C R O W N • B R I D G ESL

W-98 Disc

R-99 Disc

Z-95 Disc

A-71 Disc

S-Blank

D-98 Disc

Customized shapes and sizes are also available.

Shapes and Sizes

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W-98 Disc Product List

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§ Compatibility:

§ Dimension:

§ Thickness:

§ Materials / Shades:

Wieland ZENO and most open architecture dental milling systems

98.4 mm disc with step

10 mm, 12 mm, 14 mm, 16 mm18 mm, 20 mm, 22 mm, 25 mm

No ShadePre-Shade: A1, A3, B1, B3, C1, C3, D2

No ShadePre-Shade: S1, S2, S3, S4, S5

ClearWhitePre-Shade: A1, A2, A3, A4, B/C

BlueWhite

T

S

Wieland ZENO is not a registered trademark of Sagemax.

R-99 Disc Product List

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§ Compatibility:

§ Dimension:

§ Thickness:

§ Materials / Shades:

Roland DWX 30/50 CAD/CAM System

99mm diameter with step

10 mm, 12 mm, 14 mm, 16 mm18 mm, 20 mm, 22 mm, 25 mm

No ShadePre-Shade: A1, A3, B1, B3, C1, C3, D2

No ShadePre-Shade: S1, S2, S3, S4, S5

ClearWhitePre-Shade: A1, A2, A3, A4, B/C

BlueWhite

T

S

Roland is not a registered trademark of Sagemax.

Z-95 Zr Disc (No Shade)

PRODUCT / MODEL REF # DIMENSION MATERIAL SHADE PACKAGE

NexxZr™T / Z-95-10-NT-WT Z9510NTWT1 Ø95 x H10 (mm) NT Zirconia White 1 Disc/Pack









NexxZr™S / Z-95-10-NS-WT Z9510NSWT1 Ø95 x H10 (mm) NS Zirconia White 1 Disc/Pack








-Highest Strength WTS

-Highest TranslucencyT WT

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A-71 Zr Disc (No Shade)


NexxZr™T / A-71-12-NS-WT A7112NSWT1 Ø71 x H12 (mm) NS Zirconia White 1 Disc/Pack






NexxZr™T / A-71-12-NT-WT A7112NTWT1 Ø71 x H12 (mm) NT Zirconia White 1 Disc/Pack







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D-98 Zr Disc (No Shade)


NexxZr™T / D-98-10-NT-WT D9810NTWT1 Ø98.4 x H10 (mm) NT Zirconia White 1 Disc/Pack









NexxZr™S / D-98-10-NS-WT D9810NSWT1 Ø98.4 x H10 (mm) NS Zirconia White 1 Disc/Pack










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Contacts

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USA HeadquartersSagemax Bioceramics, Inc.34210 9th Ave. S. Suite 118Federal Way, WA 98003, USA

Toll Free: 1-877-386-0389Phone: 1-253-214-0389

[email protected]

ItalySagemax Europe SRLVia Principe Amedeo 320121 Milano, Italy

Phone: ++39 (0)39- 9518160

[email protected]

GermanySagemax Dental GmbHRigaer Str. 1410247 Berlin, Germany

Toll Free: 0800-184-4294Phone: +49 7822 437343

[email protected]

RussiaSagemax Russia34/1 Novy Arbat Street, Suite 601121099 Moscow, Russian Federation

Phone: +7 495 580 55 62

[email protected]

Hong KongSagemax Distribution Center1-11 Ka Ting Road, Kwai Chung, N.T.,Hong Kong

[email protected]

NetherlandsSagemax Distribution CenterValkweg 11118 EC SchipholThe Netherlands

[email protected]

zirconia / color / pmma / wax sagemax · : the highest strength dental zirconia. 1500 mpa. it has...

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