PROCERA IMPLANT BRIDGE OVERDENTURE

K090069 · Nobel Biocare AB · NHA · May 7, 2009 · Dental

Device Facts

• Record ID: K090069
• Device Name: PROCERA IMPLANT BRIDGE OVERDENTURE
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: May 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Procera® Implant Bridge Overdenture is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

Device Story

Procera Implant Bridge Overdenture is a custom-fabricated overdenture bar; attaches to dental implants or abutments to provide retention and support for removable dentures. Fabricated individually based on patient-specific instructions and models. Materials include titanium, titanium/vanadium alloy, or chromium/cobalt alloy. Used in dental clinics by clinicians to restore chewing function in partially edentulous patients. Device serves as a structural interface between implants and removable prosthetic components (resin composite or porcelain veneer).

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Titanium, titanium/vanadium alloy, or chromium/cobalt alloy. Form factor: Custom-milled overdenture bar. Interface: Attaches to dental implants/abutments. No software or electronic components.

Indications for Use

Indicated for partially edentulous patients requiring an overdenture bar attached to implants or abutments to restore chewing function.

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

• Procera Implant Bridge (K041236)
• Procera Implant Bridge (K043042)
• CAM StructurSURE Precision Milled Bars (BIOMET 3i)

Submission Summary (Full Text)

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K090069

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MAY .

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

| Submitted by: | Herbert Crane, Director Global Regulatory Affairs |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 5074 |
| Facsimile: | [phone] |
| Date of Submission: | January 9, 2009 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary<br>or Model Name: | Procera ^® Implant Bridge Overdenture |
| Legally Marketed Devices: | Nobel Biocare - Procera Implant Bridge (K041236)<br>Nobel Biocare - Procera Implant Bridge (K043042)<br>BIOMET 3i - CAM StructurSURE Precision Milled Bars |

### Device Description:

Nobel Biocare's Procera® Implant Bridge Overdenture is an overdenture bar that attaches to implants or abutments. The Procera® Implant Bridge Overdenture provides retention and support for a removable denture made of standard laboratory dental materials such as resin composite or porcelain veneer.

Procera® Implant Bridge Overdentures are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium, titanium/vanadium alloy, or chromium/cobalt alloy.

The Procera® Implant Bridge Overdenture implant interfaces are the predicate Procera Implant Bridges.

#### Indications for Use:

The Procera® Implant Bridge Overdenture is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAY - 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K090069

Trade/Device Name: Procera Implant Bridge Overdenture Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 1, 2009 Received: May 4, 2009

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.

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Renner

Susan Runner, D.D.S., MA Acting 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): K090069

Device Name: Procera Implant Bridge Overdenture

Indications For Use:

The Procera Implant Bridge Overdenture is indicated for use as an overdenture bar that attaches to implants or abulments in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

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)

Kien M. Slig for MSR

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

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