NUPRO® cavity varnish is indicated for the coating or occlusion of exposed dentin tubules under temporary restorations, and for the treatment of hypersensitive teeth.

Device Description

The NUPRO® cavity varnish is an ethanol based, sodium fluoride containing cavity varnish. The material is applied to tooth surfaces where hypersensitivity is a concern or to surfaces where dentinal tubule occlusion is indicated. The varnish is applied by a dentist to intact tooth surfaces, or to exposed dentin as a pre-treatment prior to application of temporary restorative materials. The material is a white opaque viscous liquid that is prepackaged in unitdose preloaded dispensing dishes with a disposable brush applicator.

AI/ML Overview

The provided document is a 510(k) summary for the NUPRO® cavity varnish, which is a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the way that an AI/software device would.

Therefore, many of the requested categories for information (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size) are not applicable to the type of device and submission described in the summary.

However, I can extract the relevant "performance data" presented in the document, which serves as the evidence for substantial equivalence, and frame it in a table format as requested.

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like a cavity varnish, "acceptance criteria" are typically related to meeting specific performance parameters that demonstrate it is as safe and effective as a legally marketed predicate device. The "reported device performance" are the results of the specific tests conducted to show this.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Biocompatibility: Device constituents are biocompatible.	"Laboratory tests on constituents of the device that are unique to the current submission demonstrate that such constituents are biocompatible."
Fluoride Content: Contains fluoride ion at the labeled concentration and is equivalent to predicates.	"Laboratory testing demonstrates that the subject device contains fluoride ion at the labeled concentration of 5% or 22,600ppm and is at least equivalent to the predicate devices which share similar labeled fluoride content."
Adhesion to Tooth Surface: Provides adhesion at least equal to predicate devices.	"Laboratory testing demonstrates that the subject device provides adhesion to the tooth surface at least equal to that of the predicate devices with an average lateral shear adhesion force of 77kPa."
Penetration of Dentin Tubules: Capable of penetrating exposed dentin tubules.	"Photomicrographs of the subject device reveal that it is capable of penetrating exposed dentin tubules to a minimum of 3-5 microns."
Prevention of Fluid Ingress: Substantially equivalent to predicates in preventing fluid ingress into dentin tubules.	"Laboratory dye penetration tests demonstrate that the subject device is substantially equivalent to the predicate devices in preventing the ingress of fluids into the exposed dentin tubules."
Conformity to Standards: Complies with relevant recognized standards.	"The NUPRO® cavity varnish was evaluated in terms of the recognized standard ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry."

Study Proving Acceptance Criteria:

The study proving the device meets the (implied) acceptance criteria is a series of laboratory tests designed to demonstrate the material and performance characteristics of the NUPRO® cavity varnish are equivalent to its predicate devices (Ascent F-Coat and DuraShield). These tests are typically conducted in vitro or ex vivo to assess specific physical, chemical, and biological properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. For material science performance tests, "test set" and "data provenance" as applied to AI/software are generally not applicable in the same way. The tests would involve laboratory samples (e.g., extracted teeth, material specimens) rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the ground truth for these types of material science and biocompatibility tests is established through objective laboratory measurements and standardized protocols, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there were no human readers or subjective interpretations requiring adjudication for these laboratory tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This device is a material (cavity varnish), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical product (cavity varnish), not an algorithm or software. Its performance is inherent to the material properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance characteristics reported (e.g., fluoride content, adhesion, tubule penetration, fluid ingress) was established through objective laboratory measurements using recognized scientific methods and standards. For example:

Fluoride content: Chemical analysis.
Adhesion: Mechanical testing (lateral shear adhesion force).
Tubule penetration: Photomicrography/microscopic examination.
Fluid ingress: Dye penetration tests.
Biocompatibility: Evaluation against ISO 7405:2008 standards.

8. The sample size for the training set

This information is not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

Summary

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K10 3160

510(k) Summary of Safety and Effectiveness

CAO Group. Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 Tel: 801-256-9282 Fax: 801-256-9287

Prepared By: Robert K. Larsen. Preparation Date: October 18, 2010

Device Name:
Trade Name:	NUPRO®
Common Name:	Cavity Varnish
Product Classification:	Varnish, Cavity

Legally Marketed Predicate Devices for Substantial Equivalence:

Ascent F-Coat, manufactured by CAO Group, Inc. (K100540) તન DuraShield, manufactured by Dentsply International. Inc. (K082198)

Rationale for Substantial Equivalence:

The aforementioned varnishes share similar indications for use on teeth for alleviating hypersensitivity with the submitted device. The predicate devices and submitted device share similar design features including the inclusion of sodium fluoride, the use of carrier solvents. application time and application methods.

Description of Submitted Device:

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Intended Uses of NUPRO®:

NUPRO® cavity varnish is indicated for the coating or occlusion of exposed dentin tubules under temporary restorations, and for the treatment of hypersensitive teeth.

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Technological Characteristics and Substantial Equivalence:

Ascent F-Coat is a 5% sodium fluoride varnish containing a total 22,600ppm equivalent fluoride ion. The varnish uses an ethanol carrier and makes use of a synthetic polymer as the varnish matrix. The product is intended for use by a dentist for the treatment of hypersensitivity and for covering exposed dentin under temporary dental restorations. The material is packaged in unit-dose blister packs and is applied by a disposable brush.

The Durashield Varnish is a 5% sodium fluoride varnish containing a total 22,600ppm equivalent fluoride ion. The varnish uses an ethanol carrier and makes use of natural resin derivatives as the varnish matrix. The product is intended for use by a dentist for the relief of hypersensitivity where exposed dentin or cementum, exist. The material is packaged in unit-dose blister packs and is applied by a disposable brush.

Conformity to Standards:

The NUPRO® cavity varnish was evaluated in terms of the recognized standard ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.

Performance Data

Laboratory tests on constituents of the device that are unique to the current submission demonstrate that such constituents are biocompatible.

Laboratory testing demonstrates that the subject device contains fluoride ion at the labeled concentration of 5% or 22,600ppm and is at least equivalent to the predicate devices which share similar labeled fluoride content.

Laboratory testing demonstrates that the subject device provides adhesion to the tooth surface at least equal to that of the predicate devices with an average lateral shear adhesion force of 77kPa.

Photomicrographs of the subject device reveal that it is capable of penetrating exposed dentin tubules to a minimum of 3-5 microns.

Laboratory dye penetration tests demonstrate that the subject device is substantially equivalent to the predicate devices in preventing the ingress of fluids into the exposed dentin tubules.

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1999 - 1999 - 1999 - 1999 Conclusion

The NUPRO® cavity varnish is substantially equivalent to the listed cavity varnishes without raising any new issues of safety or effectiveness. This device shares similar intended uses, similar formulation, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 6 2011

Mr. Robert K. Larsen Regulatory Affairs Manager CAO Group, Incorporated 4628 West Skyhawk Drive West Jordan, Utah 84084

Re: K103160

Trade/Device Name: NUPRO® Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: October 21, 2010 Received: October 26, 2010

Dear Mr. Larsen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Larsen

Enclosure

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

103160 510(k) Number (if known):

Device Name:

Indications For Use:

NUPRO® cavity varnish is indicated for the coating or occlusion of exposed dentin tubules under temporary restorations, and for the treatment of hypersensitive teeth.

Prescription Use X AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Suan Rianen

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

510(k) Number: K103160
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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.