Cleared Traditional

K991492 - LC COMPOSITE

K991492 is the FDA 510(k) clearance for LC COMPOSITE by Harry J. Bosworth Co.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K991492 · Harry J. Bosworth Co. · Dental device
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Dec 1999
Decision
218d
Days
Class 1
Risk

K991492 is an FDA 510(k) clearance for the LC COMPOSITE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on December 2, 1999 after a review of 218 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Harry J. Bosworth Co. devices

Submission Details

510(k) Number K991492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date December 02, 1999
Days to Decision 218 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 127d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 66
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K991492.
W & H ASSISTINA
K010127 · A-Dec, Inc. · Oct 2001
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K993526 · A-Dec, Inc. · Jan 2000
ENDO-EZE MOTOR AND HANDPIECE
K992380 · Ultradent Products, Inc. · Oct 1999
SYNEA-HS HIGH SPEED-HANDPIECE
K992011 · A-Dec, Inc. · Sep 1999
MODEL MS-2 HANDPIECE
K982050 · Parkell, Inc. · Sep 1998