(15 days)
Mycone Dental's denture material, known as Diamond D, is intended to form new dentures or to repair fractured dentures. It is to be used only by professional dental practitioners who make or repair dentures for patients.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "Diamond D High Implant Denture Material." It indicates that the device has been found substantially equivalent to a predicate device. However, the letter does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily states:
- The device name, regulation number, regulation name, and product code.
- The FDA's determination of substantial equivalence.
- General controls and additional controls applicable to the device.
- Contact information for further inquiries.
- The "Indications For Use" for the device, which states it is "intended to form new dentures or to repair fractured dentures" and "to be used only by professional dental practitioners who make or repair dentures for patients."
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This type of detail would typically be found in the 510(k) submission document itself, not in the clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2003
Mr. Larry Steffier Mycone Dental Supply Company Incorporated 616 Hollywood Avenue Cherry Hill, New Jersey 08002
Re: K032773
Trade/Device Name: Diamond D High Implant Denture Material Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: September 5, 2003 Received: September 8, 2003
Dear Mr. Steffier:
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 such 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 -Ms. Steffier
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 (OS) 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 vour 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Simon Runne
Susan Runner, DDS, MA Interim 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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510(k) Number (if known): K032773
Device Name: Diamond D High Impact Denture Material
Indications For Use:
Mycone Dental's denture material, known as Diamond D, is intended to form new dentures or to repair fractured dentures. It is to be used only by professional dental practitioners who make or repair dentures for patients.
M. Uphu for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032773
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.