(56 days)
Indirect cementation of ceramic, composite and metal inlays, onlays, crowns, bridges, posts, screws and veneers.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for a dental cement (trade name "seT"). It does not contain any information about acceptance criteria or a study that proves the device meets those criteria for an AI or medical device that would have such a study.
The document is a regulatory approval notice, confirming that the dental cement "seT" is substantially equivalent to a legally marketed predicate device. This type of clearance does not typically involve the detailed performance studies or AI-specific evaluation metrics you've requested.
Therefore, I cannot extract the information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document.
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Public Health Service
JUN 15 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ray Cahill Director, Sales and Marketing Southern Dental Industries, Incorporated 5-9 Brunsdon Street Bayswater, P.O. Box 314 Victoria 3153 AUSTRALIA
Re: K051008 Trade/Device Name: Set Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: June 06, 2005 Received: June 08, 2005
Dear Mr. Cahill:
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 Amendrants, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, or a concesting Act (Act) that do not require approval of a premarket approval application (PMA). Tou may, therefore, market the device, subject to the general controls provisions of the Act. To general controls provisions of the Act include requirements for annual registration, 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 an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mee publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Ray Cahill
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 complive ith 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 wour 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" (21 CFR 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.
Jenette y. Michael Davis.
Chiu S. Lin, PhD 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 (if known): K O5 j00 g
Device Name:
seT
´ Indications For Use:
Indirect cementation of ceramic, composite and metal inlays, onlays, crowns, bridges, posts, screws and veneers.
(PLEASE 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)
-Counter Use:
(Division Sinr neral Hosnit: (Optional Format 1-2-96)
510(k) Number
§ 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.