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K Number
K991492
Device Name
LC COMPOSITE
Manufacturer
HARRY J. BOSWORTH CO.
Date Cleared
1999-12-02

(218 days)

Product Code
EFB
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

LC Composite

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to Harry J. Bosworth Company for their device "LC Composite". It does not contain information about acceptance criteria, study details, or performance metrics. Therefore, it is impossible to extract the requested information from this document.

The letter confirms that the device is substantially equivalent to a predicate device and allows it to be marketed. The "Indications for Use" statement simply says: "LC Composite is indicated for use in anterior and posterior restorations with its esthetics and strength."

To answer your questions, one would need access to the actual 510(k) submission document (K991492), which would contain the performance data and details of any studies conducted.

§ 872.4200 Dental handpiece and accessories.

(a)
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.(b)
Classification. Class I.