LC PIT & FISSURE SEALANT

K991902 · Bosworth Co. · EBC · Jul 26, 1999 · Dental

Device Facts

• Record ID: K991902
• Device Name: LC PIT & FISSURE SEALANT
• Applicant: Bosworth Co.
• Product Code: EBC · Dental
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

LC Pit & Fissure Sealant is a clear, light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth, and restorations to help protect against caries.

Device Story

LC Pit & Fissure Sealant is a light-activated dental material used by dental professionals to seal pits and fissures in primary or permanent posterior teeth and restorations. The sealant is applied to the tooth surface and cured using a dental light source. By creating a physical barrier, the sealant protects the treated areas against the development of dental caries. It is intended for use in a clinical dental setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-activated dental sealant material. Formulated for application to posterior teeth and restorations. Polymerization initiated via external dental light source.

Indications for Use

Indicated for sealing pits and fissures in primary or permanent posterior teeth and restorations to protect against caries in dental patients.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 1999

Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076-3999

K991902 Re: LC Pit & Fissure Sealant Trade Name: Requlatory Class: II Product Code: EBC Dated: May 26, 1999 Received: June 4, 1999

Dear Ms. Goldstein:

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 Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Goldstein

this response to your premarket notification Please note: 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.

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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510(K) Number:

Device Name: LC Pit & Fissure Sealant

## INDICATIONS FOR USE:

LC Pit & Fissure Sealant is a clear, light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth, and restorations to help protect against caries.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-the-Counter Use (Optional Format 1/2/96)

Susan Ranne

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