Revolution Formula 2 is a flowable, light cure hybrid resin restorative designed to be used as a filling material for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Device Description

The device is a light cured, hybrid resin dental restorative which incorporates BIS-GMA chemistry along with a proprietary glass filler (approximately 60%) to yield a flowable non-slumping anong with a propriously gass into (epport 2 combination of flowability and direct application system simplifies material placement and minimizes finishing to result in a consistently superior restoration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental restorative material, "Revolution Formula 2." It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study measuring acceptance criteria and device performance in a clinical or standalone setting.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not available in the provided document. The document primarily discusses the device description, intended use, and substantial equivalence to a legally marketed predicate device (Kerr Corporation, Prodigy 3).

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The 510(k) summary focuses on asserting substantial equivalence based on similar material composition and intended use, rather than presenting specific quantitative acceptance criteria and performance data from a clinical trial or bench test against those criteria.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided. The document does not describe a clinical "test set" or provide details on any studies (clinical or otherwise) with specific sample sizes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided. As no "test set" study is described, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set:

This information is not provided. No adjudication method is mentioned as no specific study of a "test set" is detailed.

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 is not applicable. The device is a dental restorative material (a physical product), not an AI diagnostic or assistance tool that would involve human "readers" or an MRMC study.

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

This is not applicable. The device is a dental restorative material, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

This information is not provided. As no specific performance study is detailed, no ground truth method is mentioned. The equivalence claim is based on the material's properties and intended use being similar to the predicate.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is a material, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable/not provided. As above, the concept of a "training set" and its associated ground truth is not relevant to this type of device submission.

Summary of available information:

Device Name: Revolution Formula 2 (Light-Curable Dental Restorative Material)
Intended Use: Restoration of Class III, Class IV, and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
Predicate Device: Kerr Corporation, Prodigy 3
Claim of Substantial Equivalence: Revolution Formula 2 is "substantially equivalent to other legally marketed devices in the United States" and functions "in a manner similar to and is intended for the same use as" the predicate product. The equivalence is based on the device being a "light cured, hybrid resin dental restorative which incorporates BIS-GMA chemistry along with a proprietary glass filler (approximately 60%) to yield a flowable non-slumping along with a proprietary glass into a composition of flowability and direct application."

The provided content is a regulatory submission for premarket notification (510(k)) and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific acceptance criteria.

Summary

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

K013647

JAN 1 6 2002

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

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared:

November 2001

Device Name:

Trade Name Revolution Formula 2 .
Common Name Light-Curable Dental Restorative Material .
Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .

Devices for Which Substantial Equivalence is Claimed:

Kerr Corporation, Prodigy 3 .

Device Description:

Intended Use of the Device:

The intended use of Revolution Formula 2 is for the restoration of Class III, Class IV, and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in norstress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Substantial Equivalence:

Revolution Formula 2 is substantially equivalent to other legally marketed devices in the United States. The dental composite restorative material marketed by Kerr Dental Materials Center functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Corporation.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2002

Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867

Re: K013647

Trade/Device Name: Revolution Formula 2 Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 02, 2001 Received: November 05, 2001

Dear Ms. Boswell:

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 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.

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Page 2 - Ms. Boswell

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 (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.

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 you 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski

Timothy A Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section I

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Material Center

510(k) Number (if known): K013647

Device Name: Revolution Formula 2

Indications For Use:

Revolution Formula 2 is a flowable, light cure hybrid resin restorative designed to be used as a
filling material for Class III, Class IV, and Class V restorations. Additional functions include:
repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress
bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions,
and core build-ups.

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.