PRODIGY- 3

K983370 · Sybron Dental Specialties, Inc. · EBF · Nov 18, 1998 · Dental

Device Facts

• Record ID: K983370
• Device Name: PRODIGY- 3
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prodigy - 3 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 Story

Prodigy-3 is a light-cured, hybrid resin dental restorative material; utilizes BIS-GMA chemistry and proprietary glass filler (approx. 55%) to achieve flowable, non-slumping consistency. Applied directly by dental professionals in clinical settings to restore tooth structure or repair dental appliances. Material placement simplifies restorative procedures and minimizes finishing requirements. Benefits include improved handling and consistent restoration quality.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured hybrid resin restorative; BIS-GMA chemistry; proprietary glass filler (approx. 55%); flowable, non-slumping form factor; manual application system.

Indications for Use

Indicated for patients requiring dental restorations including Class III, IV, and V cavities, enamel defect repair, porcelain restoration repair, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealing, ceramic/composite veneer cementation, incisal abrasion treatment, and core build-ups.

Regulatory Classification

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.

Predicate Devices

• Kerr Corporation, Revolution

Submission Summary (Full Text)

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NOV 1 8 1998

sds K983370

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

### Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

September 1998 Date Summary Prepared:

# Device Name:

- Trade Name Prodigy 3 .
- 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, Revolution
#### Device Description:

The device is a light cured, hybrid resin dental restorative which incorporates BIS-GMA chemistry along with a proprietary glass filler (approximately 55%) to vield a flowable nonslumping restorative material. Prodigy - 3's combination of flowability and direct application system simplifies material placement and minimizes finishing to result in a consistently superior restoration.

#### Intended Use of the Device:

The intended use of Prodigy - 3 is for the restoration of Class III, Class IV, and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal buildups in non-stress bearing areas, sealing pits and fissures, cementing ceramic/composite veneers, incisal abrasions, and core build-ups.

# Substantial Equivalence:

Prodigy - 3 is substantially equivalent to other legally marketed devices in the United States. The composite restorative material marketed by Kerr Corporation functions in a manner similar to and is 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1998

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

K983370 Re : Trade Name: Prodigy - 3 Requlatory Class: II Product Code: EBF Dated: September 23, 1998 September 24, 1998 Received:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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Section I - Indications for Use

510(k) Number:

K983370

Prodigy - 3 Device Name:

Indications for Use:

Prodigy- 3 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.

Susan Pupper
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K983370

**Prescription Use**
(Per 21 CFR 801.109)