NOBEL/PROCERA IMPLANT BRIDGE

K091848 · Nobel Biocare AB · NHA · Oct 16, 2009 · Dental

Device Facts

• Record ID: K091848
• Device Name: NOBEL/PROCERA IMPLANT BRIDGE
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Oct 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NobelProcera 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.

Device Story

NobelProcera Implant Bridge is a custom-fabricated titanium bridge framework designed to attach to dental implants or abutments. The device is manufactured individually based on patient-specific instructions and models. It serves as a structural foundation for dental prostheses, which are finished by dental laboratories using standard materials like resin composite or porcelain veneer. The device is used by dental professionals in a clinical setting to restore chewing function in edentulous or partially edentulous patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Material: Titanium. Form factor: Custom-fabricated bridge framework. Intended for attachment to dental implants or abutments. No software or electronic components.

Indications for Use

Indicated for patients with partially or totally edentulous jaws requiring a bridge framework 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 Overdenture (K090069)
• Procera Implant Bridge (K043042)

Submission Summary (Full Text)

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K091848

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

## OCT 1 6 2009

| 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: | June 19, 2009 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary<br>or Model Name: | NobelProcera Implant Bridge |
| Legally Marketed Devices: | Nobel Biocare - Procera Implant Bridge Overdenture (K090069)<br>Nobel Biocare - Procera Implant Bridge (K043042) |

#### Device Description:

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

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

#### Indications for Use:

The NobelProcera 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.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

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

## OCT 1 6 2009

Re: K091848

Trade/Device Name: NobelProcera Implant Bridge Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 13, 2009 Received: October 15, 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 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/Reporta Problem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Funone

Susan Runner, D.D.S., M.A 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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# Indications for Use

510(k) Number (if known): Ko91848

Device Name: NobelProcera Implant Bridge

Indications For Use:

The NobelProcera 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.

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, Qffice of Device Evaluation (ODE)

Suvek Summy

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

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510(k) Number: K091548