The device is a micro-hybrid light cured resin-based dental restorative which contains approximately 79% by weight (59% by volume) inorganic filler but with a particle size nearly half that of Kerr's Herculite XRV and Prodigy. This breakthrough in filler technology provides a higher, longer-lasting polish similar to a microfill, without any negative effects to the physical properties.

AI/ML Overview

The provided text is a 510(k) summary for a dental composite restorative material called "Prodigy 4." It details the device's description, intended use, and its claim of substantial equivalence to existing legally marketed devices. However, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence, which is a regulatory pathway for medical devices. For this type of device, substantial equivalence is primarily established by comparing its physical and chemical properties, intended use, and performance characteristics to those of predicate devices already on the market. It does not typically require the submission of clinical study data with acceptance criteria in the same way a novel high-risk device might.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

Summary

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4/6/99

Image /page/0/Picture/1 description: The image shows a handwritten string of characters, which appears to be a combination of letters and numbers. The string reads 'K990898'. The characters are written in a cursive style, with varying stroke thicknesses. The image has a simple composition, focusing solely on the handwritten string against a plain background.

SYBRON DINTAL SPECIALTIES

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

March 1999 Date Summary Prepared:

Device Name:

Trade Name Prodigy 4 ●
Common Name Dental Composite Restorative Material .
Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .

Devices for Which Substantial Equivalence is Claimed:

Kerr Corporation, Prodigy .
Vivadent. Heliomolar .

Device Description:

Intended Use of the Device:

The intended use of Prodigy 4 is for use in all classes of cavities.

Substantial Equivalence:

Prodigy 4 is substantially equivalent to several other legally marketed devices in the United States. The dental composite restoratives marketed by Kerr Corporation and Vivadent function in a manner similar to and are intended for the same use as the product manufactured by Kerr Dental Materials Center.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of unity and connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 6 1999

Ms. Colleen Boswell Senior Requlatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

Re : K990898 Prodigy 4 Trade Name: Regulatory Class: 『II Product Code: EBF March 17, 1999 Dated: Received: March 18, 1999

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Boswell

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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898

Section I - Indications for Use

510(k) Number: K990898

Prodigy 4 Device Name:

Indications for Use:

material composite restorative material intended to be used in all
e classes of cavities.

Susan Ranney

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.