DYRACT SEAL COMPOMER PIT & FISSURE SEALANT

K992516 · Dentsply Intl. · EBC · Aug 27, 1999 · Dental

Device Facts

• Record ID: K992516
• Device Name: DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
• Applicant: Dentsply Intl.
• Product Code: EBC · Dental
• Decision Date: Aug 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT is used for preventive sealing of pits and fissures in the primary and secondary dentition.

Device Story

DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT is a light-curing dental material designed for the preventive sealing of pits and fissures in primary and secondary teeth. The device contains releasable fluoride to provide additional protection to the sealed areas. It is intended for use by dental professionals in a clinical setting. The material is applied to the tooth surface and cured using a light source. By sealing pits and fissures, the device acts as a physical barrier to prevent the development of dental caries. The formulation utilizes components previously cleared in other legally marketed DENTSPLY devices.

Clinical Evidence

Bench testing only. Physical properties meet ISO Standard 6874. Biocompatibility supported by prior use of components in legally marketed devices and negative Ames testing results.

Technological Characteristics

Light-curing compomer material containing releasable fluoride. Physical properties conform to ISO Standard 6874. Components are identical to those used in previously cleared DENTSPLY devices.

Indications for Use

Indicated for preventive sealing of pits and fissures in primary and secondary dentition.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Predicate Devices

• Delton® FS Direct Delivery System (K982564)
• Dyract® Flow Restorative (K982395)

Submission Summary (Full Text)

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# 510(k) SUMMARY

NAME & ADDRESS:

## DENTSPLY International

0 West College Avenue ork. PA 17405-0872 171845.7511 17,854,2343

P. J. Lehn Telefax [phone]

P. Jeffery Lehn CONTACT:

DATE PREPARED:

TRADE OR PROPRIETARY NAME: DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT

872.3765 CLASSIFICATION NAME: Pit and fissure sealant and conditioner

K982564 Delton® FS Direct Delivery System PREDICATE DEVICES: K982395 Dyract® Flow Restorative

DEVICE DESCRIPTION: DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT is a light curing pit and fissure sealant containing releasable fluoride offers an additional protection of the sealed pits and fissures.

The physical properties of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT meet ISO Standard 6874.

INTENDED USE: DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT is used for preventive sealing of pits and fissures in the primary and secondary dentition.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT have been used in legally marketed devices.

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

We believe that biocompatibility studies with the final formulation are not necessary, due to the prior use of all components in DENTSPLY legally marketed devices.

Therefore, we believe that the prior use of the components of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT in legally marketed devices, the similarity in composition to the predicate device, the performance data, and the results of Ames and previous biocompatibility testing support the safety and effectiveness of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT for the indicated uses.

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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 features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1999

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

K992516 Re: Dyract® Seal Composer Pit & Fissure Sealant Trade Name: Regulatory Class: II EBC and EBF Product Code: Dated: July 27, 1999 Received: July 28, 1999

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜ 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 - 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

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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## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

K992516

Device Name: DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT

Used for preventive sealing of pits and fissures in the primary and secondary dentition.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Ryan

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

000007