QUICKSET LIQUID AND POWDER by SPECIALITES SEPTODONT

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Quickset™ Liquid and Powder," which is a quick-setting temporary restorative material.

The letter states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to devices marketed prior to May 28, 1976. However, it does not provide details about:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for any test sets.
The number or qualifications of experts used to establish ground truth.
Adjudication methods.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
Whether a standalone (algorithm only) performance study 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.

This document is a regulatory clearance and not a scientific study report.

Summary

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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOV

Specialites Septodont C/O Mr. Peter S. Reichertz Counsel for Specialites Septodont Arent Fox Kintner Plotkin & Kahn, PLLC 1050 Connecticut Avenue N.W. Washington, DC 20036-5339

Re : K982773 Quickset™ Liquid and Powder Trade Name: Requlatory Class: II Product Code: EMA Dated: Auqust 6, 1998 Received: August 7, 1998

Dear Mr. Reichertz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices; General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Reichertz

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda,gov/cdrh/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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510(k) Nunber (if known):

Device Name: Quickset™ Liquid and Powder

Indications For Use:

Quickset™ is a quick-setting temporary restorative material.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEADED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Aran unw (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

5100x) Number 510(k) Number 12 Over-The-Counter Use OR X

(Optional Formal 1-2-96)

02/13 '96 11:07

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 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.