BONE GRAFT SCREW SYSTEM

K973056 · Bicon, Inc. · DZL · Nov 12, 1997 · Dental

Device Facts

• Record ID: K973056
• Device Name: BONE GRAFT SCREW SYSTEM
• Applicant: Bicon, Inc.
• Product Code: DZL · Dental
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bicon Bone Graft Screws are indicated for those cases where a clinician intends to augmenting and replacing bone that has been lost.

Device Story

Bone Graft Screw System used by dental clinicians to stabilize bone graft material during surgical procedures. Device functions as mechanical fixation to augment or replace lost bone. Used in clinical dental settings. Output is physical stabilization of graft site; assists clinician in bone reconstruction; benefits patient by facilitating bone regeneration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bone graft screw; mechanical fixation device. Materials and dimensions not specified. Non-powered, manual surgical instrument.

Indications for Use

Indicated for patients requiring bone augmentation or replacement due to bone loss. For use by clinicians.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 1997

Vincent J. Morgan, D.M.D. ·President Bicon Dental Implants 1153 Centre Street Boston, Massachusetts 02130

Re : K973056 Bone Graft Screw System Trade Name: Regulatory Class: II Product Code: DZL Dated: August 12, 1997 Received: Auqust 15, 1997

Dear Dr. Morgan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Dr. Morqan

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Bone Graft Screw System

Image /page/2/Picture/1 description: The image shows the logo for Bicon Dental Implants. The word "bicon" is written in a bold, sans-serif font, with a small triangle above the "i". Below the word "bicon" is the phrase "DENTAL IMPLANTS" in a smaller, sans-serif font. The letters are black on a white background.

## XII. Indications for Use Statement

The Bicon Bone Graft Screws are indicated for those cases where a clinician intends to attact has The Dicon Done Graft Delevis are mercase of augmenting and replacing bone that has been lost.

Susan Plunnes

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

510(k) Number K973036

Prescrintion Use ... (Per 21 CFR 801.109)