DYRACT AP RESTORATIVE

K973235 · Dentsply Intl. · EBF · Feb 5, 1998 · Dental

Device Facts

• Record ID: K973235
• Device Name: DYRACT AP RESTORATIVE
• Applicant: Dentsply Intl.
• Product Code: EBF · Dental
• Decision Date: Feb 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

DYRACT® AP RESTORATIVE is used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth: as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root caries lesions: and for core build-up.

Device Story

DYRACT AP RESTORATIVE is a one-component, visible light-curing dental restorative material supplied in COMPULES. Upon exposure to a dental curing light, monomers polymerize and cross-link, forming polymer-containing carboxyl groups that react with cations eluted from glass-reinforcing filler to form a salt. This process hardens the material. Used by dental professionals in clinical settings for various restorative procedures, including cavity filling, base lining, and core build-ups. The device is a modification of the predicate DYRACT II, engineered to provide enhanced strength and wear resistance.

Clinical Evidence

Bench testing only. The device was evaluated using the Ames Mutagenicity Test and Guinea Pig Sensitization Test. Results indicated the cured material is non-mutagenic and a non-sensitizer.

Technological Characteristics

One-component, visible light-cured dental resin. Composition includes monomers and glass-reinforcing filler. Hardening occurs via polymerization and subsequent salt formation between carboxyl groups and eluted cations. Delivered in COMPULES. Non-mutagenic and non-sensitizing.

Indications for Use

Indicated for use as a permanent restorative material in all cavity classes for both permanent and deciduous teeth, as a base material under amalgams, ceramics, cast metal restorations, and composites, for laminate or open sandwich techniques, for root caries lesions, and for core build-up.

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

• DYRACT® II Restorative (K950991)

Submission Summary (Full Text)

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# 510(k) SUMMARY

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### NAME & ADDRESS:

K973235-

#### DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 [phone] Fox 171718542343

P. J. Lehn Telefax [phone]

| CONTACT: | P. Jeffery Lehn | |
|----------------------------|----------------------------|----------|
| DATE PREPARED: | August 27, 1997 | |
| TRADE OR PROPRIETARY NAME: | DYRACT® AP RESTORATIVE | |
| CLASSIFICATION NAME: | Tooth resin shade material | 872.3690 |
| PREDICATE DEVICE: | DYRACT® II Restorative | K950991 |

DYRACT® AP RESTORATIVE is a one-component, visible light DEVICE DESCRIPTION: curing, dental restorative material, delivered in COMPULES®, which hardens upon polymentation. The composition is polymenzed by brief exposure to visible light from a dental curing light. When polymenzation occurs, the monomers cross-link to form polymer-containing carboxyl groups which are capable of further reaction with cations eluted from the glass-reinforcing filler to form a salt, as in DYRACT® II Restorative (K950991). The modifications to the DYRACT II Restorative serve to enhance the strength and wear resistance of DYRACT AP RESTORATIVE.

The physical properties of DYRACT AP RESTORATIVE and the predicate device are similar.

INTENDED USE: DYRACT AP RESTORATIVE is used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth: as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root caries lesions: and for core build-up.

TECHNOLOGICAL CHARACTERISTICS: All components in DYRACT AP RESTORATIVE have been used in legally marketed devices or found to be safe for dental use.

DYRACT AP RESTORATIVE (cured material) was tested by the Ames Mutagenicity Test and Guinea Pig Sensitization Test. The cured material is non-mutagenic and a non-sensitizer.

We believe that the prior use of the components of DYRACT AP RESTORATIVE in legally marketed predicate devices, the results of the toxicity and sensitization testing, and the performance data support the safety and effectiveness of DYRACT AP RESTORATIVE for the indicated uses.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 1998

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405

K973235 Re : DYRACT® AP RESTORATIVE Trade Name: Regulatory Class: II Product Code: EBF January 28, 1998 Dated: January 30, 1998 Received:

Dear Mr. Lehn:

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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes .compliance .with ........ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Lehn

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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

Timo Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

K973235

Device Name:

DYRACT® AP RESTORATIVE

Indications for Use:

Used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth; as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root canes lesions; and for core build-up

Concurence of CDRH. Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices K973233
Prescription Use
OR
Over-The-Counter Use

000007