CHLORAPREP by CENTRIX, INC. | FDA 510(k) Summary

This FDA 510(k) clearance letter for the CHLORAPREP™ device, a cavity varnish (Regulation Name: Cavity Varnish, Product Code: LBH), indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.

The letter primarily focuses on the regulatory aspects of the clearance, such as:

Substantial Equivalence: The FDA has determined the device is substantially equivalent to predicate devices.
Regulatory Classification: The device is classified as Class II (Special Controls).
Compliance Requirements: It outlines the manufacturer's responsibilities regarding registration, listing, labeling, and good manufacturing practices.

Therefore, I cannot provide the requested information based on the provided text.

To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would typically include:

A table of acceptance criteria and the reported device performance: This would detail the specific performance metrics (e.g., bond strength, fluoride release, antimicrobial efficacy) and the thresholds for acceptance, along with the results of tests conducted.
Sample size used for the test set and the data provenance: This would specify how many samples were tested and where the data came from (e.g., in vitro lab studies, in vivo animal studies, human clinical trials, and their geographical origin and design).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is more relevant for imaging or diagnostic devices where human interpretation is involved. For a cavity varnish, ground truth would likely be established through objective laboratory measurements or histological analysis.
Adjudication method for the test set: Again, more relevant for subjective evaluations. For a material, it would be based on validated assays.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This is typically for diagnostic imaging devices, not a cavity varnish.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable to this type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Would likely be lab measurements (e.g., chemical composition, physical properties, antimicrobial activity).
The sample size for the training set: Not applicable as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Without the actual study report or performance data from the 510(k) submission, it's impossible to describe the acceptance criteria or the study demonstrating compliance.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized, interconnected shapes that resemble human profiles or abstract forms. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 2 6 2002

Mr. John Discko Executive Vice President Centrix, Incorporated 770 River Road Shelton, Connecticut 06484-5458

Re: K021131 Trade/Device Name: CHLORAPREPTM Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: July 11, 2002 Received: July 16, 2002

Dear Mr. Discko:

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 cither 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.

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Page 2 – Mr. Discko

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 (OS) 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 vou 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Timoth A. Ulatowski 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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Page of

5:0(k) NUMBER (IF KNOWN) 021 DI'VICE NAME: INDICATIONS FOR USE:

CLEANING AND Disinfective RESTORA ીચ્ચનો work

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

✓
Prescription Use OR Over-The-Counter-Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)

Susan Rame
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: (0) 131

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.