PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052

K043042 · Nobel Biocare AB · NHA · Nov 18, 2004 · Dental

Device Facts

• Record ID: K043042
• Device Name: PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants: 3i® 3.75 - Lifecore® Biomedical Restore 3.75 · Zimmer® Dental Taper-lock 4.0 · Sterngold Implamed® 3.75

Device Story

Procera® Implant Bridge is a custom-fabricated titanium bridge framework; attaches to endosseous dental implants or abutments. Device serves as structural foundation for dental prostheses; finished by dental laboratory using standard materials like resin composite or porcelain veneer. Fabricated individually per patient-specific instructions and models. Used in dental clinics by clinicians to restore function in edentulous patients. Interfaces designed to match external hexagon connectors of specific predicate implant systems. Benefits include restoration of chewing function through secure prosthetic support.

Clinical Evidence

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

Technological Characteristics

Material: Titanium. Form factor: Custom-fabricated bridge framework. Interface: Hexagon connector compatible with specific external hexagon endosseous implants. Manufacturing: Patient-specific fabrication based on models/instructions. No software or electronic components.

Indications for Use

Indicated for partially or totally edentulous patients requiring dental restoration of chewing function via bridge framework attached to endosseous 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

• Procera® Implant Bridge (K041236)
• 3i Dental Abutment (K032263)
• Restore Self-Tapping Dental Implant System (K954512)
• Taper-lock Dental Implant System (K011038)
• Sterngold ImplaMed Hex Implant (K981516)

Submission Summary (Full Text)

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

| Submitted by: | Elizabeth J. Mason, Sr. Regulatory Affairs Specialist |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC.<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | November 3, 2004 |
| Classification Name: | Endosseous Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary<br>or Model Name: | Procera® Implant Bridge<br>Legally Marketed Devices: Procera® Implant Bridge (K041236)<br>3i Dental Abutment (K032263)<br>Restore Self-Tapping Dental Implant System (K954512)<br>Taper-lock Dental Implant System (K011038)<br>Sterngold ImplaMed Hex Implant (K981516) |

## Device Description:

Nobel Biocare's Procera® Implant Bridge is a bridge framework that attaches to implants or abutments. The Procera® Implant Bridge framework is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.

Procera® Implant Bridges are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium.

The Procera® Implant Bridge implant interfaces are modeled after similar interfaces currently available for the predicate devices listed.

## Indications for Use:

The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring function. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants:

- 318 3.75 -
- Lifecore® Biomedical Restore 3,75 -
- Zimmer® Dental Taper-lock 4.0 .
- Sterngold Implamed® 3.75 -

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2004

Nobel Biocare AB C/O Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K043042

Trade/Device Name: Procera® Implant Bridge Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 3, 3004 Received: November 4, 2004

Dear Ms. Mason:

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 such additional controls. Existing major regulations affecting vour 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. Mason

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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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# Indications for Use

510(k) Number (if known): K043042

Device Name: Procera® Implant Bridge

Indications For Use:

The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants:

• 3i® 3.75

- Lifecore® Biomedical Restore 3.75
· Zimmer® Dental Taper-lock 4.0

· Sterngold Implamed® 3.75

Prescription Use X (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)

Ken Moley ka MSR

(Division Sign-Off) Page 1 of 1 . . pital, Division of Ane Infection Control.

510(k) Number: K043042

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