BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.

Device Description

The applicant device is a Brushable Dental Composite, classified as a Tooth Shade Resin Material. It is a low viscosity microfilled composite with a filler percentage of 36%. It is supplied as preloaded, plastic syringes. The material is extruded onto a suitable pad or well and applied to the instrument.

AI/ML Overview

This document is a 510(k) summary for a dental composite, not a study report for a medical device with acceptance criteria and performance data in the typical sense of AI/ML or diagnostic devices.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided text, addressing the applicable points:

This document describes a 510(k) submission for a dental material (Brushable Composite) seeking substantial equivalence to a predicate device. It is not a clinical study report for a diagnostic or AI-powered medical device where performance metrics like sensitivity, specificity, or inter-reader agreement are typically established against predefined acceptance criteria.

Applicable Information from the Provided Text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The primary "acceptance criterion" for a 510(k) dental material is demonstrating substantial equivalence to a legally marketed predicate device. This is primarily assessed through comparison of intended use, composition, physical/mechanical aspects, and how the product is supplied and used. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
- Reported Device Performance (Comparative Information): The provided table compares the applicant device (Cosmedent BRUSHABLE COMPOSITE) to the predicate device (Bisco SCULPTING RESIN). This table serves as the basis for demonstrating substantial equivalence rather than reporting explicit performance metrics against numerical acceptance criteria.

Feature / Aspect	Acceptance Criterion (Implicit for Substantial Equivalence)	Cosmedent BRUSHABLE COMPOSITE (Applicant Device)	Bisco SCULPTING RESIN (Predicate Device)
Intended Use	Intended Use is substantially similar	Used to manipulate and sculpt esthetic dental restorative materials	Used to manipulate and sculpt esthetic dental restorative materials
Composition	Substantially same chemical composition	Light-cure, silica filled, difunctional acrylic composites	Light-cure, silica filled, difunctional acrylic composites
Physical/Mechanical Aspects	Similar physical and mechanical properties	Low viscosity microfilled composites	Low viscosity microfilled composites
How Supplied & Used	Similar packaging and application method	Supplied as preloaded, plastic syringes; extruded onto pad/well	Supplied as preloaded, plastic syringes; extruded onto pad/well
Filler Percentage	(Difference noted, but still considered substantially equivalent)	36%	30%

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document describes a comparison to a predicate device based on material characteristics, not a clinical study with a "test set" of patient data.
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):
- Not Applicable. There is no "ground truth" derived from expert review of a test set in this 510(k) submission. The ground for equivalence relies on material science comparisons.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication process is described.
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:
- Not Applicable. This is a dental material, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a dental material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the traditional sense. For this 510(k), the "truth" is established by comparing the physical, chemical, and functional properties of the new device to those of the predicate device, typically using standardized material testing methods relevant to dental composites (which are not detailed in this summary). The FDA's determination of "substantial equivalence" is the regulatory ground truth.
The sample size for the training set:
- Not Applicable. No "training set" is involved as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not Applicable. No "training set" or corresponding ground truth establishment is applicable here.

Summary

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K092730

Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for BRUSHABLE COMPOSITE

Page 13 of 14

REVISED

510(k) SUMMARY

NOV 2 0 2009

As required by the Safe Medical Devices Act of 1990

DESCRIPTION OF THE APPLICANT DEVICE

TRADE NAME: BRUSHABLE COMPOSITE COMMON NAME: Brushable Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF)

Indications for Use: Cosmedent BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.

The technological characteristics of the applicant device are essentially identical to the predicate device.

IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

TRADE NAME: Bisco SCULPTING RESIN COMMON NAME: Brushable Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF) 510(k) Number: K030585

EQUIVALENTS	CosmedentBRUSHABLECOMPOSITE	Bisco Sculpting Resin
Similarities
Intended Use	Both products are intended to be used to manipulate andsculpt esthetic dental restorative materials
Composition	Both products have substantially the same chemicalcomposition. They are light-cure, silica filled,difunctional acrylic composites
Physical/mechanical Aspects	Both products are low viscosity microfilled compositesand have similar physical and mechanical properties
How supplied and used	Both products are supplied as preloaded, plasticsyringes. The material is extruded onto a suitable pad orwell and applied to the instrument
Differences
Filler percentage	36%	30%

SUBSTANTIAL EQUIVALENCE SUMMARY

Submitted by: James L. Sandrik, PhD Cosmedent, Inc. 401 N. Michigan Ave. Suite 2500 Chicago, IL 60611

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

. . . . . . .

NOV 2 0 2009

James L. Sandrik, Ph. D Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611

Re: K092730

Trade/Device Name: Brushable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 3, 2009 Received: November 4, 2009

Dear Dr. Sandrik:

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 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 - Dr. Sandrik

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting 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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K092730

Cosmedent, Inc., 401 N. Michigan Ave., Suite 2500 _60611 510(k) submission for BRUSHABLE COMPOSITE Page 4 of 14

REVISED

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: MULTIPLE (BRUSHABLE COMPOSITE)

Indication For Use:

BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, achinting, and repair of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muluy for Mise

(Division Sign-Off)

· Mision of Anesthesiology, General Hospital infection Control. Dental Devices

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Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.