NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS

K101714 · Nobel Biocare AB · NHA · Aug 31, 2010 · Dental

Device Facts

• Record ID: K101714
• Device Name: NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Aug 31, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NobelProcera Ti Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

Device Story

Endosseous dental implant abutment; connects directly to Thommen SPI dental implants; provides platform for prosthetic restoration. Individually designed and machined per patient requirements. Materials: CP titanium or titanium/vanadium alloy. Used in oral cavity; operated by dental professionals. Output: physical prosthetic interface. Benefit: enables prosthetic rehabilitation for patients with dental implants.

Clinical Evidence

No clinical data. Safety and effectiveness supported by non-clinical bench testing, specifically fatigue testing of worst-case platform samples in accordance with FDA Class II Special Controls Guidance for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Technological Characteristics

Materials: CP titanium or titanium/vanadium alloy. Form factor: patient-specific machined abutment. Compatibility: Thommen SPI implant platforms (3.5, 4.0, 4.5, 5.0, 6.0). Energy source: none (mechanical). Sterilization: not specified.

Indications for Use

Indicated for use as an aid in prosthetic rehabilitation for patients requiring dental implant restoration. Compatible with Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

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

• NobelProcera Ti Abutment (K091756)
• Thommen Medical AG - SPI Easy 4.0 Abutment (K071457)
• Thommen Medical AG - SPI Dental Implant Abutments (K031747)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Herbert Crane<br>Director, Global Regulatory Affairs | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 | AUG 31 2010 |
| Telephone: | [phone] | |
| Facsimile: | [phone] | |
| Date of Submission: | June 17, 2010 | |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| Trade or Proprietary<br>or Model Name: | NobelProcera Ti Abutment Thommen Platforms | |
| Legally Marketed Devices: | Nobel Biocare - NobelProcera Ti Abutment (K091756)<br>Thommen Medical AG - SPI Easy 4.0 Abutment (K071457)<br>Thommen Medical AG - SPI Dental Implant Abutments (K031747) | |

## Device Description:

Nobel Biocare's NobelProcera Ti Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.

The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.

### Indications for Use:

The NobelProcera Ti Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

#### Summary of testing to demonstrate safety and effectiveness

Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples in accordance with the FDA quidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates That the device is safe and effective for its intended use and performs as well or better than the predicate devices.

Nobel Biocare Special 510(k) Notification NobelProcera Ti Abutments Thommen Platforms June 2010

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Substantial Equivalence Comparison to Predicate Devices

など

| ATTRIBUTE | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design/<br>construction | Nobel Procera Ti<br>Abutment<br>Thommen Platforms | NobelProcera Ti Abutment<br>(K091756) | Thommen Medical AG<br>SPI Easy 4.0 Abutment<br>(K071453) | Thommen Medical AG<br>SPI Dental Implant Abutments<br>(K031747) |
| Anatomical<br>Site | Patient specific / machined<br><br>Oral Cavity | Patient specific / machined<br><br>Oral Cavity | Patient specific / machined<br><br>Oral Cavity | Patient specific / machined<br><br>Oral Cavity |
| Platform<br>compatibility | Thommen<br>SPI implant systems platform<br>3.5, 4.0, 4.5, 5.0, 6.0 | Nobel Biocare<br>Brånemark NP, RP, WP<br>Replace NP, RP, WP, 6.0<br>Active NP, RP | Thommen<br>SPI implant systems platform<br>4.0 | Thommen<br>SPI implant systems platform<br>3.5, 4.5, 5.0, 6.0 |
| | | Astra Tech<br>Yellow, Aqua, Lilac | | |
| | | Straumann<br>Octagon 3.5, 4.8, 6.5<br>Bone Level 3.3, 4.1/4.8 | | |
| | | BIOMET 3i<br>Internal 3.4, 3.75/4.0, 5.0, 6.0<br>External 3.4, 4.1, 5.0, 6.0 | | |
| Device<br>Material | CP Titanium<br>Titanium/vanadium alloy | CP Titanium<br>Titanium/vanadium alloy | CP Titanium | CP Titanium |
| Indications for<br>Use | The Nobel Procera Ti<br>Abutments are<br>premanufactured prosthetic<br>components directly<br>connected to endosseous<br>dental implants and are<br>intended for use as an aid in<br>prosthetic rehabilitation. | The Nobel Procera Ti Abutments<br>are premanufactured prosthetic<br>components directly connected to<br>endosseous dental implants and<br>are intended for use as an aid in<br>prosthetic rehabilitation. | The Thommen SPI Easy 4.0<br>Abutment is intended to be used<br>in conjunction with SPI System<br>dental implants in the maxillary<br>and/or mandibular arch to<br>provide support for crowns,<br>bridges or overdentures. | The Thommen SPI Dental Implant<br>Abutments are intended to be<br>used in conjunction with SPI<br>System dental implants in the<br>maxillary and/or mandibular arch<br>to provide support for crowns,<br>bridges or overdentures. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which features a stylized caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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

Nobel Biocare AB C/O Mr. Herbert Crane Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

AUG 31 2010

Re: K101714

Trade/Device Name: NobelProcera Ti Abutment Thommen Platforms Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 2, 2010 Received: August 3, 2010

Dear Mr. Crane:

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- Mr. Crane

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 device-related 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.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Klol 714

Device Name: NobelProcera Ti Abutment Thommen Platforms

Indications For Use:

The NobelProcera Ti Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

Rei Mulley for HSR

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

000020 510(k) Number: K | 0 \ 7 | 4