(158 days)
Utilized by a dental Heath-care profession.) for making high-definition dental impressions. as port of dental prosthesis procedures.
Not Found
I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, or ground truth establishment. The document appears to be a 510(k) premarket notification letter from the FDA, discussing the substantial equivalence of a dental impression device, but it lacks the specific technical details you're looking for.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 9 1999
Mr. W.R. Glace Vice President, Research and Production Den-Mat Corporation 2727 Skyway Drive Santa Maria, California 93455
Re : K983106 1ºº Impression Trade Name: Regulatory Class: II Product Code: ELW Dated: December 10, 1998 December 11, 1998 Received:
Dear Mr. Glace:
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Glace
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA dinding of substantial equivalence of your device to a legally rinding of babban 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 office or comprisid, "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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- 510(k) Number (if known): k-983106
Device Name:
Indications For Use:
Utilized by a dental Heath-care profession.)
for making high-definition dental impressions.
as port of dental prosthesis procedures.
(trlease do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Susan Puma
Over-The-Counter Use
(Optional Form 1-2-96)
(Division Sign-Off) (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Devices Division of Demail Devices વિત્ત 510(k) Number
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).