NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236

K033724 · Nobel Biocare Uas, Inc. · NHA · Feb 23, 2004 · Dental

Device Facts

• Record ID: K033724
• Device Name: NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: NHA · Dental
• Decision Date: Feb 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center a temporary abutment and act as a seal to prohibit fluids from seeping into the implant interior during temporization. The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.

Device Story

Nobel Biocare Centric Post is a hollow accessory component for dental implant systems; functions as an alignment post to center abutments and as a seal to prevent fluid ingress into the implant interior. Used during the fabrication of temporary restorations; remains inside the implant/abutment interface while the implant is in the patient's mouth. Does not contact oral mucous membranes. Operated by dental professionals in a clinical setting. Enhances performance of the implant/abutment system by ensuring proper alignment and protecting the implant interior, thereby supporting the restoration of chewing function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hollow accessory component; designed for placement within the implant/abutment interface. Functions as a mechanical alignment guide and fluid seal. Non-patient contacting. Standalone component integrated into existing dental implant systems.

Indications for Use

Indicated for fully or partially edentulous patients requiring dental implant restoration; used as an alignment post and fluid seal for temporary abutments within an implant system.

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

• Replace® Scalloped Margin Implant System (K021584)
• Nobel Perfect Implant System (K030257)

Submission Summary (Full Text)

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FEB 2 3 2004

K033724

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

| Submitted by: | Elizabeth J. Mason, Sr. Regulatory Affairs Specialist |
|----------------------------------------|----------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA Inc.<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | November 21, 2003 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | Nobel Biocare Centric Post |
| Legally Marketed Device(s): | Replace® Scalloped Margin Implant System (K021584)<br>Nobel Perfect Implant System (K030257) |

## Device Description:

Nobel Biocare's Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior.

The Nobel Biocare Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth.

These attributes of the Nobel Biocare Centric Post enhance the performance of the implant/abutment system, such as the Nobel Perfect Implant System, and make the component desirable for use in fabricating both final restorations and temporary restorations.

## Indications for Use:

The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center an abutment and as a seal to prohibit fluids from seeping into the implant interior.

The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2004

Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K033724

Trade/Device Name: Nobel Biocare Centric Post Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: November 21, 2003 Received: November 26, 2003

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 Intersule ecomments of process 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 approvisions 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 (1 Writ), it may of basys 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. or the rece of any - 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 your 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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Owe

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): K033724

Device Name: Nobel Biocare Centric Post

Indications For Use:

The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center a temporary abutment and act as a seal to prohibit fluids from seeping into the implant interior during temporization.

The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.

Susan Quares

Division of Anesthesiology, General Hospital, Infection Control, Dental Devi

510(k) Number: K033724

× 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 E.valuation (ODE)

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