(161 days)
Curative Dental Acrylic Teeth are preformed plastic denture teeth intended for use as teeth in dentures.
Curative Dental Acrylic Teeth are preformed plastic denture teeth.
The provided text describes the 510(k) premarket notification for "Curative Dental Acrylic Teeth." It states that "Data were provided to demonstrate that the Curative Dental Acrylic Teeth comply with applicable safety and performance standards." However, the document does not include specific acceptance criteria, detailed study designs, or performance results. It focuses on the regulatory submission and FDA's determination of substantial equivalence to predicate devices based on the same or similar materials and intended use.
Therefore, I cannot provide accurate information for most of your requested points based only on the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Data were provided to demonstrate... compliance," but it does not specify what those data were, what the acceptance criteria were, or the actual performance results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The text does not mention any sample sizes for testing or the provenance of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. This type of information is not relevant to a device like dental acrylic teeth, which do not typically require expert interpretation of images or other subjective data to establish a "ground truth" in the way an AI diagnostic device would.
4. Adjudication method for the test set
- Cannot be provided. As above, this is not applicable for this type of device and study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. This is explicitly an AI-related study type and is not relevant to "Curative Dental Acrylic Teeth."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This is an AI-related study type and is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. For this type of product, "ground truth" would likely refer to established material properties and functional tests rather than clinical outcomes or pathology. However, the document does not specify these.
8. The sample size for the training set
- Cannot be provided. This is an AI-related term and is not relevant to a traditional medical device like dental acrylic teeth.
9. How the ground truth for the training set was established
- Cannot be provided. This is an AI-related term and is not relevant.
In summary, the provided document is a regulatory approval letter for a medical device (dental acrylic teeth), not a scientific study detailing performance criteria and results in the way one would find for a diagnostic or AI-powered device. It indicates that some performance data were submitted to the FDA to demonstrate compliance with standards, leading to a determination of substantial equivalence, but it does not disclose the specifics of those data or the studies themselves.
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AUG 2 5 2006
510(k) Premarket Notification for the Curative Dental Acrylic Teeth
COMPANY NAME AND ADDRESS 1.
Sponsor 1.1
Curative, LLC 2275 East Bayshore Road, Suite 105 Palo Alto, CA 94303 Telephone: 650-856-9600 Facsimile: 650-856-9601
1.2 Manufacturer
Shanghai Dental Materials Factory Shanghai Medical Instruments Co., Ltd No. 690 Tian Tong An Road Shanghai, China, 200081 Telephone: 86-21-56664470 Facsimile: 86-21-65402339
1.3 Consultant/Contact
Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
| Primary Contact: | James R. Veale |
|---|---|
| Telephone: | 719-495-3438 |
| Facsimile: | 719-495-3438 |
2. DEVICE NAME
| Proprietary Name: | Curative Dental Acrylic Teeth |
|---|---|
| Common/Usual Name: | Acrylic Denture Teeth |
| Classification Name: | Preformed plastic denture tooth (21CFR 872.3590) |
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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Curative Dental Acrylic Teeth are intended for the same purpose as the predicate products, and are made of the same or similar materials.
PERFORMANCE TESTING 7.
Data were provided to demonstrate that the Curative Dental Acrylic Teeth comply with applicable safety and performance standards.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that resemble a person's head and torso. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2006
Curative, LLC C/O Mr. James R. Veale Senior Technical Adviser Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K060720
Trade/Device Name: Curative Dental Acrylic Teeth Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: July 27, 2006 Received: July 28, 2006
Dcar Mr. Veale:
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 – Mr. Veale
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 (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), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Clive
Chin-Lin, Ph.D.
Chiu Lin, Ph.D 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:
1060720
Device Name: Curative Dental Acrylic Teeth
Indications For Use:
Curative Dental Acrylic Teeth are preformed plastic denture teeth intended for use as teeth in dentures.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER
CONTINUE OF AND THE WEST VESTIGATIO PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei. Muly for MHR
Sign-Off)
thesiology, General Hospital,
librish of Anesthesiolo I ් 1 ු(k) Number:
§ 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.