DMC Composite 2 High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, small endo access restorations, repair of porcelain restorations, repair of composite restorations and acrylic restorations, and repair of temporaries.

DMC Composite 2 Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal buildups in non-stress bearing areas, incisal abrasions, small endo access restorations, repair of composite and acrylic restorations, and repair of temporaries.

Device Description

DMC Composite 2 is a self-adhesive, light cured resin based composite dental restorative designed for direct placement. DMC Composite 2 is offered in both high viscosity and low viscosity formulations, and is indicated for all caries classes. This product contains 82% filler by weight and is radiopaque.

AI/ML Overview

The provided document is a 510(k) summary for a dental composite restorative material, DMC Composite 2. It describes the device, its intended use, and claims substantial equivalence to predicate devices. It explicitly states that no clinical testing was performed for this product. Therefore, the device doesn't have "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial demonstrating performance metrics against set thresholds.

Instead, the submission relies on the concept of substantial equivalence to legally marketed predicate devices based on similar technological/performance characteristics. The document focuses on regulatory approval rather than a detailed performance study with acceptance criteria.

However, I can extract the relevant information based on the premise of substantial equivalence as the "proof" the device meets regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical performance study was conducted, there are no specific quantitative acceptance criteria or reported device performance metrics in the document. The "acceptance criteria" here are implicitly being met by demonstrating substantial equivalence to predicate devices, which are already approved and presumed safe and effective.

Acceptance Criteria	Reported Device Performance (based on substantial equivalence)
Safety and Biocompatibility	Presumed through similar formula and substantial equivalence to legally marketed predicate devices (Premise, Premise Flowable, Optibond Solo Plus 2), as the additional indications do not result in formula changes.
Similar Technological/Performance Characteristics	DMC Composite 2 functions in a manner similar to Premise and Premise Flowable (for repair of all caries classes and repair of composite, acrylic, and porcelain restorations) and Optibond Solo Plus 2 (as a self-adhesive, light-cured resin-based composite dental restorative for direct placement).
Intended Use	Meets the intended use for direct restorations of all caries classes, core buildup, small endo access, repair of porcelain, composite, acrylic, and temporary restorations for High Viscosity, and Class I, II (base/liner), III, V restorations, pit and fissure sealant, repair of enamel defects, blocking out undercuts, minor occlusal buildups, incisal abrasions, small endo access, repair of composite, acrylic, and temporary restorations for Low Viscosity, similar to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No clinical test set was used. The submission relies on non-clinical data and comparison to predicate devices.
Data Provenance: Not applicable for a test set. The data provenance for the claim of substantial equivalence is based on the characteristics of the predicate devices which are legally marketed in the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set with expert-established ground truth was used.

4. Adjudication method for the test set

Not applicable. No clinical test set was used.

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

Not applicable. This device is a dental restorative material, not an AI-assisted diagnostic or treatment planning tool. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used

Not applicable in the context of a performance study. The "ground truth" for the regulatory submission is the established safety and effectiveness of the legally marketed predicate devices to which DMC Composite 2 claims substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm and does not have a training set or associated ground truth.

Summary based on the provided document:

The regulatory approval for DMC Composite 2 is based on non-clinical test data and a claim of substantial equivalence to existing legally marketed dental composite restorative materials (Predicate Devices: Premise, Premise Flowable, Optibond Solo Plus 2). The document explicitly states: "Clinical testing has not been conducted on this product." The rationale is that the "addition of the new indications would not result in any formula changes to DMC Composite 2, there is no reason to suspect that the safety and biocompatibility of DMC Composite 2 would be adversely affected." Therefore, the "study" proving the device meets criteria is essentially the analysis of its formulation and intended use in comparison to known, approved devices, without new clinical trials.

Summary

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<103351

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo appears to be in black and white.

JAN 2 0 2011

" |

SYBRON DENTAL SPECIALTIES

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: November 2010

Device Name:

· Trade Name DMC Composite 2
· Common Name Dental Composite Restorative Material
· Classification Name ~ Tooth Shade Resin Material, per 21 CFR § 872.3690

Devices for Which Substantial Equivalence is Claimed:

· Premise, Kerr Corporation
· Premise Flowable, Kerr Corporation
Optibond Solo Plus 2, Kerr Corporation

Device Description:

Intended Use of the Device:

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Substantial Equivalence:

DMC Composite 2 is substantially equivalent to other legally marketed devices in the United States. DMC Composite 2 functions in a manner similar to Premise and Premise Flowable, marketed by Kerr Corporation, in that it is intended for the repair of all caries classes as well as the repair of composite, acrylic, and porcelain restorations. In addition, DMC Composite 2 functions in a manner similar to Optibond Solo Plus 2, marketed by Kerr Corporation as Optibond Solo Plus, in that it is a self-adhesive, light cured resin based composite dental restorative designed for direct placement. The only difference between this 510(k) submission and the original 510(k) submission is the addition of the following new indications for use: Small endo access restorations, repair of composite and acrylic restorations, and repair of temporaries.

Non-Clinical Test Data

Because the addition of the new indications would not result in any formula changes to DMC Composite 2, there is no reason to suspect that the safety and biocompatibility of DMC Composite 2 would be adversely affected.

Clinical Testing

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the similar technological/performance characteristics as compared to the predicate devices, the new indications being added to DMC Composite 2 are deemed to be substantially equivalent to the predicate devices, Premise and Premise Flowable, marketed by Kerr Corporation and Optibond Solo Plus 2, marketed by Kerr Corporation as Optibond Solo Plus.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.

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

Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

JAN 20 2011

Re: K103351

Trade/Device Name: DMC Composite 2 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF and EBC Dated: November 15, 2010 Received: November 16, 2010

Dear Ms. Garman:

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 vour device in the Federal Register.

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Page 2- Ms. Garman

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/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

510(k) Number (if known): K103351

Device Name: DMC Composite 2

Indications For Use:

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

Division Sign-Off

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices Page 1 of 1

1:10(k) Number:	K103351
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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.