(64 days)
INDICATIONS : Class V cavities (particularly erosion lesions). Class III cavities. Posterior cavities in deciduous teeth. 'Sticky' pits and fissures. Free-hand veneering.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental cement product. It is a regulatory approval document and does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML device.
The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices, where performance metrics like sensitivity, specificity, or AUC are critical and established through rigorous studies.
This document, however, pertains to a traditional medical device (dental cement) where "performance" is assessed through different means, often involving material properties and clinical experience, not through the kind of statistical analysis of a test set with ground truth that your questions imply.
Therefore, I cannot provide answers to your specific questions based on the provided text.
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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 & 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 a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Public Health Service
- 9 2002
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Advanced Healthcare Limited C/O Mr. Perry Kashfian Pearson Dental Supply Company 13161 Telfair Avenue Sylmar, California 91342
Re: K020376
Trade/Device Name: AHL Generic Glass Ionomer Aesthetic Restorative Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA and EBF Dated: January 31, 2002 Received: February 04, 2002
Dear Mr. Kashfian:
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. Perry Kashfian
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 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 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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AHL Generic Glass Ionomer Aesthetic Restorative
ATTACHMENT #4
INDICATIONS FOR USE
510(k) Number: number not yet assigned (KOLO376 )
AHL Generic Glass Ionomer Aesthetic Restorative Device Name:
INDICATIONS : Class V cavities (particularly erosion lesions). Class III cavities. Posterior cavities in deciduous teeth. 'Sticky' pits and fissures. Free-hand veneering.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.
Susan Rianney
n - ( 15-5) ntal, Infection Control,
510 (k)
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.