(78 days)
Intended for Use as a long-term resilient lining material for removable dentures, and to reline, repair, clasp or rebase dentures.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the given input. The document is essentially a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices, not a detailed study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
NOV 1 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thermoelastic Technologies, Incorporated C/O Mr. Arthur Ward Medical Device Consultant Regulatory & Marketing Services, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K012882
R012002
Trade/Device Name: Bitem Angel Reline Kit, Bitem Laboratory Kit, Model 12011 Regulation Number: 872.3760 Regulation Name: Resin, Denture, Relining, Repairing, Rebasing Regulatory Class: I Product Code: EBI Dated: June 18, 2001 Received: August 28, 2001
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your because of 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 Intersule commerce prior sthat have been reclassified in accordance with the provisions of Ameliuments, or to act research tic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or 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 (1 Nr.), It hay of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routish further announcements concerning your device in the Federal Register.
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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 not the Act or any Federal statutes and regulations administered by other Federal agencies. or the rice of ally I outstal state s requirements, including, but not limited to: registration r ou inust comply with and are rabeling (21 CFR Part 801); good manufacturing practice and instills (21 OF Fer at 807), availty systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quadis ion 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 1110 letter warket 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 If you desire up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Alalator A
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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NOV 1 4 ZUUI
510(k) Number (if known):
ThermoElastic Technologies Inc .- BITEM Thermoelastic Material Device Name:
Indications For Use:
Intended for Use as a long-term resilient lining material for removable dentures, and to reline, repair, clasp or rebase dentures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rinne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number 10)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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.