LC COMPOSITE

K991492 · Harry J. Bosworth Co. · EFB · Dec 2, 1999 · Dental

Device Facts

• Record ID: K991492
• Device Name: LC COMPOSITE
• Applicant: Harry J. Bosworth Co.
• Product Code: EFB · Dental
• Decision Date: Dec 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

LC Composite is indicated for use in anterior and posterior restorations with its esthetics and strength

Device Story

LC Composite is a dental restorative material used by dentists for anterior and posterior restorations. It provides esthetic and structural properties for tooth repair. The device is applied by a clinician in a dental office setting to restore tooth structure. It functions as a restorative composite resin.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental composite resin material for restorative applications. Class II device.

Indications for Use

Indicated for anterior and posterior dental restorations.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

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

K991492 Re : LC Composite Trade Name: Regulatory Class: II Product Code: EFB Dated: November 15, ਹੈ ਕੇ ਰੇ ਰੇ Received: November 23, 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, qood 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. 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

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Page 2 - Ms. Goldstein

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 regulation (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 one royet 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,

Patricia Cucenita //a

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: K991492

Device Name: LC COMPOSITE

## INDICATIONS FOR USE:

LC Composite is indicated for use in anterior and posterior restorations with its esthetics and strength

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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

Susan Dunne

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

C.L.