The Ascent F-Coat cavity varnish is an ethanol based varnish agent containing 5% sodium fluoride. The material is applied to tooth surfaces where hypersensitivity is a concern The varnish is applied by a dentist to intact tooth surfaces, or to exposed dentin as a pre-I he varilish is upplication of temporary restorative materials. The material is a white opaque treamient prof to upprication of temperation of the present of in preloaded dispensing syringes with disposable brush tips.

AI/ML Overview

The provided text describes a 510(k) summary for a dental product called Ascent F-Coat, which is a cavity varnish. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for a novel medical device that would typically involve extensive performance data and clinical trials.

Therefore, many of the requested categories for a comprehensive study report (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance) are not explicitly present in the provided text. The information available is mainly related to laboratory testing demonstrating equivalence.

Here's an analysis of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Ascent F-Coat)
Fluoride Ion Concentration	Contains fluoride ion at the labeled concentration of 5% or 22,600ppm.
Adhesion to Tooth	Provides adhesion to the tooth of 77kPa.
Penetration of Exposed Dentin Tubules	Capable of penetrating exposed dentin tubules to a minimum of 3-5 microns (based on photomicrographs).
Prevention of Fluid Ingress (Dye Penetration)	Substantially equivalent to predicate devices in preventing the ingress of fluids into the exposed dentin tubules (based on laboratory dye penetration tests).
Biocompatibility	Conforms to ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.

Study Details:

Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for any of the laboratory tests (e.g., how many teeth were tested for adhesion, how many samples for dye penetration).
- Data provenance is not explicitly stated. The tests are described as "Laboratory testing," implying they were conducted in a lab environment. There is no indication of retrospective or prospective human data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The performance data seems to be based on objective laboratory measurements rather than expert human assessment for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as the performance data is based on laboratory measurements, not subjective evaluations requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a dental varnish, not an AI-powered diagnostic tool, so such a study would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical dental product, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance data appears to be objective physical and chemical measurements (e.g., fluoride concentration, adhesion force, penetration depth, dye penetration inhibition). Biocompatibility would be assessed against the ISO standard.
The sample size for the training set:
- Not applicable. This is a physical product, not a machine learning model requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of the Study (as described):

The "study" described is a series of laboratory tests demonstrating that the Ascent F-Coat cavity varnish is "substantially equivalent" to two legally marketed predicate devices (Vanish Varnish and DuraShield). The focus is on demonstrating similar technological characteristics and performance rather than proving a novel clinical benefit through a large-scale clinical trial.

The key findings from these laboratory tests are:

The device contains the labeled 5% (22,600ppm) sodium fluoride.
It provides an adhesion to the tooth of 77kPa.
Photomicrographs show it penetrates exposed dentin tubules to a minimum of 3-5 microns.
Dye penetration tests indicate it is "substantially equivalent" to predicate devices in preventing fluid ingress into dentin tubules.
It conforms to the ISO 7405:2008 standard for biocompatibility.

The purpose of these tests was to support the claim of substantial equivalence for 510(k) clearance, asserting that the device does not raise new questions of safety or effectiveness compared to predicate devices.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string starts with the letter 'K', followed by the numbers '100540'. The handwriting is somewhat cursive, with the numbers and letters connected to each other.

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

Robert Larsen, Preparation Date: August 23, 2010

Device Name:

Trade Name:	Ascent F-Coat
Common Name:	Cavity Varnish
Product Classification:	Varnish, Cavity

Legally Marketed Predicate Devices for Substantial Equivalence:

Vanish Varnish, manufactured by 3M Company (K090519)

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 incorporation of sodium fluoride and carrier solvents, application time and application methods.

Description of Submitted Device:

SEP 2 3 2010

5-1

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Intended Uses of Ascent F-Coat:

The device is intended for the coating of exposed dentin under temporary restorations, and for the treatment of hypersensitive teeth.

Technological Characteristics and Substantial Equivalence:

The Vanish 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 equiratives as the variish matrix. The product is intended for use by a dentist for the treatment of hypersensitivity, for use on exposed dentin, and 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 cement, exist. The material is packaged in unit-dose blister packs and is applied by a disposable brush.

Conformity to Standards:

The Ascent F-Coat 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 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.

Share Simmar Robers nates that the subject device provides adhesion to the tooth of 77kPa.

a.
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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The Ascent F-Coat cavity varnish is substantially equivalent to the listed cavity varnishes without raising any issues of safety or effectiveness. This device shares similar intended uses, 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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

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

SEP 2 3 2010

Trade/Device Name: Ascent F-Coat Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish

Regulatory Class: II Product Code: LBH Dated: August 30, 2010 Received: September 3, 2010

Dear Mr. Larsen:

Re: K100540

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

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 (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.

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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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

Enclosure

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Indications for Use

100540 SEP 2 3 2010

KID 0540 510(k) Number (if known):

Device Name: Ascent F-Coat

Indications For Use:

Ascent F-Coat is indicated for the coating of exposed dentin under temporary restorations, and for the treatment of hypersensitive teeth.

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Puons

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

510(k) Number: K100340
Page 1 of 1

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.