(89 days)
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.
Bone Graft Screw System
I am sorry, but the provided text from the FDA 510(k) letter for the "Bone Graft Screw System" does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.
The letter is a notification of substantial equivalence for a medical device submitted on November 12, 1997. It primarily focuses on the regulatory approval and classification of the device based on its substantial equivalence to previously marketed devices. The key information it provides is:
- Device Name: Bone Graft Screw System
- Trade Name: (Not explicitly stated in the provided text, but likely related to Bicon Dental Implants, the submitter).
- Regulatory Class: II
- Product Code: DZL
- Indications for Use: "The Bicon Bone Graft Screws are indicated for those cases where a clinician intends to attach bone grafts in the process of augmenting and replacing bone that has been lost."
- Submitter: Vincent J. Morgan, D.M.D., President, Bicon Dental Implants.
- Date of Submission: August 12, 1997
- Date of Receipt: August 15, 1997
- FDA Decision: Substantially Equivalent, allowing marketing under general controls provisions.
To answer your request, a detailed performance study with acceptance criteria would typically be found in the 510(k) summary or the full 510(k) submission, neither of which is included in the provided text. The letter only refers to "indications for use stated in the enclosure," and then that enclosure states the generic indication for bone graft screws.
Therefore, I cannot provide the requested table and study details based on the given input.
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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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.