R-30 AESTHETIC RESTORATIVE

K984387 · Dentsply Intl. · EBF · Jan 13, 1999 · Dental

Device Facts

• Record ID: K984387
• Device Name: R-30 AESTHETIC RESTORATIVE
• Applicant: Dentsply Intl.
• Product Code: EBF · Dental
• Decision Date: Jan 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

R-30 AESTHETIC RESTORATIVE is to be used with Prime & Bond® NT™ Dental Adhesive System for cavity classes I, II, III, IV, V and VI in anterior and posterior teeth as a direct restorative material, anterior direct veneering material, and may be used for the fabrication of indirect inlays and onlays.

Device Story

R-30 AESTHETIC RESTORATIVE is a visible light-activated, radiopaque composite restorative material. Used in dental clinics by dentists for anterior and posterior tooth restorations. Applied in conjunction with Prime & Bond® NT™ Dental Adhesive System. Packaged in syringes or compules for direct placement into prepared tooth cavities. Material cures upon exposure to visible light, providing structural restoration of tooth anatomy. Benefits include aesthetic tooth repair and functional restoration of primary and permanent teeth.

Clinical Evidence

Bench testing only. Physical properties meet ISO 4049 standards. Biocompatibility supported by prior use of components in predicate device and negative Ames testing results.

Technological Characteristics

Visible light-activated, radiopaque composite restorative material. Packaged in syringes or compules. Meets ISO 4049 physical property standards. No software or electronic components.

Indications for Use

Indicated for patients requiring restoration of primary and permanent teeth for cavity classes I-VI, anterior direct veneering, and fabrication of indirect inlays and onlays.

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

• SureFil™ High Density Posterior Restorative (K973221)

Submission Summary (Full Text)

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## 510(k) SUMMARY

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NAME & ADDRESS:

DENTSPLY International

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

JAN 1 3 1999

K984387

P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn

December 3, 1998 DATE PREPARED:

TRADE OR PROPRIETARY NAME: R-30 AESTHETIC RESTORATIVE

COMMON OR USUAL NAME: Dental restorative material

CLASSIFICATION NAME: Tooth resin shade material

PREDICATE DEVICE: SureFil™ High Density Posterior Restorative K973221

R-30 AESTHETIC RESTORATIVE is a visible light activated, DEVICE DESCRIPTION: radiopaque restorative material for anterior and posterior restorations of primary and permanent teeth. It is to be used with Prime & Bond® NT™ Dental Adhesive System. The material is a one-component, VLC composite restorative, packaged in syringes or compules.

The physical properties of R-30 AESTHETIC RESTORATIVE meet ISO Standard 4049.

INTENDED USE: R-30 AESTHETIC RESTORATIVE is to be used with Prime & Bond® NT™ Dental Adhesive System for cavity classes I, II, III, IV, V and VI in anterior and posterior teeth as a direct restorative material, anterior direct veneering material, and may be used for the fabrication of indirect inlavs and onlays.

TECHNOLOGICAL CHARACTERISTICS: The new R-30 AESTHETIC RESTORATIVE is substantially equivalent to the predicate device, K973221 (SureFil™ High Density Posterior Restorative).

We believe that the prior use of the R-30 AESTHETIC RESTORATIVE components in the predicate device supports our decision that additional biocompatibility studies with the final formulation are not necessary.

The results of Ames testing on the main components were negative.

We believe that the prior use of the components in the R-30 AESTHETIC RESTORATIVE in the predicate device, the performance data provided, and the results of previous biocompatibility testing support the safety and effectiveness of R-30 AESTHETIC RESTORATIVE for the intended uses.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 1999

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

K984387 Re : R-30 Aesthetic Restorative Trade Name: Requlatory Class: II Product Code: EBF Dated: December 3, 1998 December 8, 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, Druq, 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 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 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) 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 Please note: this response to your the Federal Register. 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 requlations.

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Page 2 - Mr. Lehn

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

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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K984387

## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

510(K) Number:

K984387

Device Name:

## R-30 AESTHETIC RESTORATIVE

R-30 AESTHETIC RESTORATIVE is to be used with Prime & Bond® NT™ Dental Adhesive System for cavity classes I, II, III, IV, V and VI in anterior and posterior teeth as a direct restorative material, anterior direct veneering material, and may be used for the fabrication of indirect inlays and onlays.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Sisen Russe

ivision of Dental, Infection Control, and General Hospital Devices

510(k) Number

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