(83 days)
TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.
TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.
This is a 510(k) clearance letter for preformed plastic denture teeth. This type of device does not typically involve the kind of studies or acceptance criteria you're asking about, as it is cleared based on substantial equivalence to a predicate device, not on AI/algorithm performance.
Therefore, I cannot provide information on the following:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document provides the following information relevant to the device:
- Device Name: TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth
- Intended Use: "TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture."
- Regulatory Class: II
- Product Code: 76 ELM
- Regulation Number: 872.3590
- Regulation Name: Preformed Plastic Denture Tooth
The FDA's decision is based on a determination of substantial equivalence to legally marketed predicate devices, meaning it has essentially the same intended use and technological characteristics as a device already on the market, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. This is a common pathway for medical device clearance and does not typically involve the rigorous performance studies required for novel AI-based diagnostic or therapeutic devices.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ruthibras Imp. Exp. Com. De Materiaia Odontologicos C/O Mr. Kevin Walls Regulatory Insight Incorporation 13 Red Fox Lane Littleton, Colorado 80127
Re: K022299
Trade/Device Name: TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: 76 ELM Dated: July 15, 2002 Received: July 16, 2002
Dear Mr. Walls:
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.
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.
OCT 0 7 2002
{1}------------------------------------------------
Page 2 -- Mr. Walls
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 (QS) 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 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 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Page 1 of 1
{ 10(k) Number (if known): Xozzz99
TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth l)evice Name:
Indicalions for Use: TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.
PLE/ SE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off)
Division of Dental, Infection Control and
General Hospital Devices
510(k) Number K022299
Pre :cription Use × (Pe 21 CFR 801.109)
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.