K Number
K021131
Device Name
CHLORAPREP
Manufacturer
Date Cleared
2002-09-26

(171 days)

Product Code
Regulation Number
872.3260
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CLEANING AND Disinfective RESTORA ીચ્ચનો work
Device Description
Not Found
More Information

Not Found

Not Found

No
The provided 510(k) summary contains no information about the device description or any mention of AI, ML, or related terms. The intended use also does not suggest AI/ML functionality.

No
The "Intended Use / Indications for Use" states "CLEANING AND Disinfective RESTORA" which indicates cleaning and disinfecting, not treating medical conditions.

No

The "Intended Use / Indications for Use" section mentions "CLEANING AND Disinfective RESTORA," which describes a function related to cleaning and disinfection rather than diagnosing a medical condition.

Unknown

The provided text is incomplete and lacks a device description, making it impossible to determine if it is a software-only medical device.

Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is described as "CLEANING AND Disinfective RESTORA ીચ્ચનો work". This language strongly suggests a cleaning and disinfection product, not a diagnostic test performed on biological samples in vitro (outside the body). The phrase "ીચ્ચનો work" is unclear, but the overall context points away from diagnosis.
  • Lack of IVD Indicators: None of the other fields provide any information that would suggest an IVD. There's no mention of:
    • Biological samples (blood, urine, tissue, etc.)
    • Measuring analytes or biomarkers
    • Providing diagnostic information
    • Specific diseases or conditions being tested for

Conclusion:

The provided information points towards a cleaning and disinfection product, which is not typically classified as an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

CLEANING AND Disinfective RESTORA ીચ્ચનો work

Product codes

LBH

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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.

1

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

2

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