NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236

K040573 · Nobel Biocare Uas, Inc. · NHA · Apr 28, 2004 · Dental

Device Facts

• Record ID: K040573
• Device Name: NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: NHA · Dental
• Decision Date: Apr 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Nobel Biocare Permanent Centric Post is a support component indicated for use as both an alignment post to center an abutment, and as a seal to prohibit fluids from seeping into the implant interior. The Nobel Biocare Permanent Centric Post is a component within the endosseous implant system, and is intented for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.

Device Story

The Nobel Biocare Permanent Centric Post is a hollow accessory component for endosseous implant systems. It functions as an alignment post to center abutments and as a seal to prevent fluid ingress into the implant interior. The device is placed within the implant/abutment interface and remains there for the duration of the implant's life. It does not contact oral mucous membranes. It is used by dental professionals during the restoration of edentulous or partially edentulous patients to support chewing function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hollow accessory component for endosseous implant systems; functions as an alignment post and fluid seal; designed for permanent placement within the implant/abutment interface.

Indications for Use

Indicated for use as an alignment post and fluid seal within an endosseous implant system for permanent restorations to restore chewing function in fully or partially edentulous patients.

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

• Nobel Biocare Centric Post (K033724)

Submission Summary (Full Text)

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### APR 2 8 2004

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

| Submitted by: | Elizabeth J. Mason<br>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: | March 3, 2004 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | Nobel Biocare Permanent Centric Post |
| Legally Marketed Device(s): | Nobel Biocare Centric Post (K033724) |

### Device Description:

Nobel Biocare's Permanent 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 Permanent 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.

### Indications for Use:

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

The Nobel Blocare Permanent Centric Post is a component within the implant system, and is intended for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.

Nobel Biocare USA, Inc. Traditional 510(k) Notification Nobel Biocare Permanent Centric Post March 2004

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Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a bird or other winged creature, possibly an eagle, with its wings spread. The image is in black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 8 2004

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

Re: K040573

Trade/Device Name: Nobel Biocare Permanent Centric Post, Models 31234, 31235 Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: March 3, 2004 Received: March 9, 2004

Dear Ms Mason:

We have reviewed your Scction 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. Fxisting major regulations affecting your device can be found in the Codc 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 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Quls

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):

Device Name: Nobel Biocare Permanent Centric Post

Indications For Use:

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

The Nobel Biocare Permanent Centric Post is a component within the endosseous implant system, and is intented for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.

× 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)

Řikuts Betz DDS for Dr. Susan Kinner

sthesiology, General Hospital Infection Control, Dental Device

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510(k) Number: K040573

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