PRODIGY 4 TRANSLUCENT SHADES

K992118 · Sybron Dental Specialties, Inc. · EBF · Aug 18, 1999 · Dental

Device Facts

• Record ID: K992118
• Device Name: PRODIGY 4 TRANSLUCENT SHADES
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: Aug 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prodigy 4 Translucent Shades is a dental composite restorative material intended to be used in all classes of cavities.

Device Story

Prodigy 4 Translucent Shades is a micro-hybrid, light-cured, resin-based dental restorative material. It contains approximately 70% by weight inorganic filler with a reduced particle size compared to previous Kerr products (Herculite XRV and Prodigy). This filler technology enables a higher, longer-lasting polish similar to a microfill without compromising physical properties. The device is used by dental professionals in a clinical setting to restore tooth structure in all classes of cavities. The material is applied to the cavity preparation and cured using a dental light source to harden the composite, providing a functional and aesthetic restoration.

Clinical Evidence

bench testing only

Technological Characteristics

Micro-hybrid, light-cured, resin-based dental composite. Contains approximately 70% by weight inorganic filler. Features reduced particle size compared to predicate. Formulated for high polishability.

Indications for Use

Indicated for use in all classes of dental cavities in patients requiring restorative treatment.

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, Prodigy 4

Reference Devices

• Kerr's Herculite XRV
• Kerr's Prodigy

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties, Inc. The word "SYBRON" is in large, bold, black letters. Below that, in smaller letters, is the text "DENTAL SPECIALTIES, INC." The logo is simple and professional.

## 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

Date Summary Prepared: June 1999

### Device Name:

- Trade Name Prodigy 4 Translucent Shades .
- 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 4
### Device Description:

The device is a micro-hybrid, light cured, resin-based dental restorative which contains approximately 70% by weight 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.

### Intended Use of the Device:

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

### Substantial Equivalence:

Prodigy 4 Translucent Shades is substantially equivalent to several other legally marketed devices in the United States. The dental composite restorative 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 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 an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1999

Ms. Colleen Boswell Manager, Requlatory Affairs Sybron Dental Specialties Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K992118 Prodigy 4 Translucent Shades Trade Name: Requlatory Class: II Product Code: EBF Dated: June 22, 1999 Received: June 23, 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), 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 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 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 regulation (21 CFR Part 801 and additionally 809.10 for in xitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and [phone]. advertising of your device, please contact the Office of Also, please note the regulation Compliance at [phone]. entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). 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,

Patricia Cincentiffer

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

Enclosure

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Section I - Indications for Use

510(k) Number:

K992118

Device Name: Prodigy 4 Translucent Shades

Indications for Use:

Prodigy 4 Translucent Shades is a dental composite restorative material intended to be used in all classes of cavities.

. .

Prescription Use _ 1 (Per 21 CFR 301.100)

Susan Runn

510(k) Number