IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE

K124008 · Ivoclar Vivadent, Agin · NHA · Mar 29, 2013 · Dental

Device Facts

• Record ID: K124008
• Device Name: IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE
• Applicant: Ivoclar Vivadent, Agin
• Product Code: NHA · Dental
• Decision Date: Mar 29, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPS e.max® Press Abutment Solutions for Nobel Biocare is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations. IPS e.max Press Abutment Solutions for Nobel Biocare is recommended for the fabrication of: - Hybrid abutments for single-tooth restorations - -Hybrid abutment crowns for restorations

Device Story

IPS e.max Press Abutment Solutions for Nobel Biocare consists of lithium disilicate glass ceramic components used to fabricate hybrid abutments or hybrid abutment crowns. These components are luted onto compatible titanium connector abutments (Ti bases) which interface with specific Nobel Biocare dental implant systems. The device is used by dental professionals in a clinical setting to restore function and aesthetics in edentulous patients. The fabrication process involves a heat/press technique to customize the ceramic part to the titanium sleeve. The final assembly is a cement-retained restoration. The device benefits patients by providing a customized, durable ceramic restoration supported by established implant interfaces.

Clinical Evidence

No clinical data was performed. Substantial equivalence was established through bench testing, specifically dynamic fatigue performance testing conducted in accordance with ISO 14801:2007.

Technological Characteristics

Material: Lithium disilicate glass ceramic. Form: Pressed ceramic components for hybrid abutments or crowns. Interface: Luted to titanium bases (Ti bases). Mechanical testing: Dynamic fatigue loading per ISO 14801:2007. Connectivity: Mechanical interface with Nobel Biocare implant systems (NobelReplace Tapered and Replace Select Tapered).

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit cement-retained restorations supported by Nobel Biocare dental implant systems.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• IPS e.max Press Abutment Solutions (K120053)

Reference Devices

• Nobel Biocare Replace Select Tapered implant system (K050705)
• Snappy Abutment (K062749)

Submission Summary (Full Text)

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# 510(K) SUMMARY

MAR 2 9 2013

### IPS e.max Press Abutment Solutions for Nobel Biocare K124008

| Contact: | Donna Marie Hartnett |
|--------------------------|--------------------------------------------------------------------------------|
| Company: | Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228<br>[phone] |
| Date Prepared: | March 7, 2013 |
| Proprietary Name: | IPS e.max Press Abutment Solutions for Nobel Biocare |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Classification Code/Reg: | NHA / 872.3630 |
| Predicate Devices: | IPS e.max Press Abutment Solutions K120053) |

Device Description: IPS e.max Press will be used to press full ceramic pressed hybrid abutment crowns, or a customized hybrid abutment part which are luted on to recommended titanium connector abutments.

The predicate device to which IPS e.max Press Abutment Solutions for Nobel Biocare has been compared is IPS e.max Press Abutment Solutions (K120053). The materials are identical as to chemical composition, performance data and indications for use, except that the predicate device was cleared for use with certain identified Straumann dental implant systems. The subject device has been tested to provide evidence of its expanded compatibility with Nobel Biocare dental implant systems as stated in the Intended Use section below.

The comparison shows that the subject device is substantially equivalent to the predicate device.

Intended Use:

IPS e.max® Press Abutment Solutions for Nobel Biocare is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations.

IPS e.max Press Abutment Solutions for Nobel Biocare is recommended for the fabrication of:

- Hybrid abutments for single-tooth restorations -
- । Hybrid abutment crowns for restorations

The following Ti bases and implant bodies are intended to be used with IPS e.max Press Abutment Solutions for Nobel Biocare.

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### 510(K) SUMMARY

#### IPS e.max Press Abutment Solutions for Nobel Biocare K124008

| Implant<br>manufacturer | Implant system, diameter | Compatible Ti base<br>(abutment), dimensions<br>gingiva height = GH<br>height = HTi |
|-------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Nobel Biocare | NobelReplace Tapered NP Ø 3.5mm,<br>Length 8, 10, 11.5, 13, 16 mm | Snappy Abutment 4.0<br>internal tri-channel<br>NP, RP, WP, 6.0<br>HTI 4.0 - 5.5mm<br>GH 0.5 - 1.5mm<br>(K062749) |
| Nobel Biocare | NobelReplace Tapered RP Ø 4.3mm,<br>Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | NobelReplace Tapered WP Ø 5.0mm,<br>Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | NobelReplace Tapered 6.0 Ø 6.0mm,<br>Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | Replace Select Tapered NP Ø 3.5mm,<br>Length 8, 10, 11.5, 13, 16 mm | (K050705) |
| Nobel Biocare | Replace Select Tapered RP Ø 4.3mm,<br>Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | Replace Select Tapered WP Ø 5.0mm,<br>Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | Replace Select Tapered 6.0 Ø 6.0mm,<br>Length 8, 10, 11.5, 13 mm | |
| Nobel Biocare | | |

Technological Characteristics: The device design, i.e. delivery form, and intended use of IPS e.max Press Abutment Solutions for Nobel Biocare and the predicate device are the same. The composition of the subject device is identical to the predicate.

Description of the performance aspects Material Composition: Lithium disilicate glass ceramic

Mechanical Properties: Fatigue tests under dynamic loading according to ISO 14801:2007 were completed using Nobel Biocare Replace Select Tapered TiU NP implant, Ø=3,5 mm, I=11.5mm and Snappy abutment 4.0 NobelReplace NP 0.75

> IPS e.max Press can be applied as abutment on which a crown is luted (two part solution) or as abutment crown (one part solution).

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# 510(K) SUMMARY

### IPS e.max Press Abutment Solutions for Nobel Biocare K124008

Implant to Abutment Compatibility: Not applicable. The interface between implant and abutment is confirmed by the titanium sleeve. By applying the heat/press technique IPS e.max Press can be processed individually on every indicated titanium sleeve.

Not applicable – components do not consist of dissimilar metals. Corrosion Testing:

Modified Surfaces: Not applicable.

Clinical Studies: Clinical testing is not required and has not been performed.

Testing Summary: The device was tested in accordance with ISO14801:2007 for Dynamic fatigue performance applicable to endosseous implant systems and the results from testing demonstrate that IPS e.max Press Abutment Solutions for Nobel Biocare is substantially equivalent to the predicate device.

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The following Ti bases are intended to be used with IPS e.max Press Abutment Solutions for Nobel Biocare.

| Implant<br>manufacturer | Implant system, diameter | Connection<br>Platform | Compatible Ti base<br>(abutment)<br>dimensions<br>gingiva height = GH<br>height = HTi |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------|
| Nobel Biocare | NobelReplace Tapered NP Ø 3.5mm, Length 8, 10, 11.5, 13, 16 mm<br>NobelReplace Tapered RP Ø 4.3mm, Length 8, 10, 11.5, 13, 16 mm<br>NobelReplace Tapered WP Ø 5.0mm, Length 8, 10, 11.5, 13, 16 mm<br>NobelReplace Tapered 6.0 Ø 6.0mm, Length 8, 10, 11.5, 13, 16 mm<br>Replace Select Tapered NP Ø 3.5mm, Length 8, 10, 11.5, 13, 16 mm<br>Replace Select Tapered RP Ø 4.3mm, Length 8, 10, 11.5, 13, 16 mm<br>Replace Select Tapered WP Ø 5.0mm, Length 8, 10, 11.5, 13, 16 mm<br>Replace Select Tapered 6.0 Ø 6.0mm, Length 8, 10, 11.5, 13 mm<br>(K050705) | Tri-Channel | Snappy Abutment 4.0 internal tri-channel NP, RP, WP, 6.0<br>HTI 4.0 - 5.5mm<br>GH 0.5 - 1.5mm<br>(K062749) |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 29, 2013

Ms. Donna Marie Hartnett Director Quality Assurance / Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive AMHERST NY 14228

Re: K124008

Trade/Device Name: IPS e.max® Press - Abutment Solutions for Nobel Biocare Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 26, 2012 Received: December 31, 2012

Dear Ms. Hartnett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Hartnett

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Kwame O.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): : K124008

Device Name: IPS e.max® Press - Abutment Solutions for Nobel Biocare

Indications For Use:

IPS e.max® Press Abutment Solutions for Nobel Biocare is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations.

IPS e.max Press Abutment Solutions for Nobel Biocare is recommended for the fabrication of:

- Hybrid abutments for single-tooth restorations -
- -Hybrid abutment crowns for restorations

Con't next page

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S 2013.03.27 11:06:35 -04'00'

for M. Susan Runner, DDS, MA

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 2

510(k) Number:

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The following Ti bases are intended to be used with IPS e.max Press Abutment Solutions for Nobel Biocare. .

| Implant<br>manufacturer | Implant system, diameter | Connection<br>Platform | Compatible Ti base<br>(abutment)<br>dimensions<br>gingiva height = GH<br>height = HTi |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------|
| Nobel Biocare | NobelReplace Tapered NP Ø 3.5mm,<br>Length 8, 10, 11.5, 13, 16 mm<br>NobelReplace Tapered RP Ø 4.3mm,<br>Length 8, 10, 11.5, 13, 16 mm<br>NobelReplace Tapered WP Ø<br>5.0mm, Length 8, 10, 11.5, 13, 16<br>mm<br>NobelReplace Tapered 6.0 Ø 6.0mm,<br>Length 8, 10, 11.5, 13, 16 mm<br>Replace Select Tapered NP Ø<br>3.5mm, Length 8, 10, 11.5, 13, 16<br>mm<br>Replace Select Tapered RP Ø<br>4.3mm, Length 8, 10, 11.5, 13, 16<br>mm<br>Replace Select Tapered WP Ø<br>5.0mm, Length 8, 10, 11.5, 13, 16<br>mm | Tri-Channel | Snappy Abutment 4.0<br>internal tri-channel<br>NP, RP, WP, 6.0<br>HTI 4.0 - 5.5mm<br>GH 0.5 - 1.5mm<br>(K062749) |
| | Replace Select Tapered 6.0 Ø<br>6.0mm, Length 8, 10, 11.5, 13 mm<br>(K050705) | | |

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