Cleared Traditional

K933505 - BOSWORTH COPALIONER

K933505 is an FDA 510(k) clearance for BOSWORTH COPALIONER, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K933505 · Harry J. Bosworth Co. · Dental device
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Jan 1994
Decision
176d
Days
Class 2
Risk

K933505 is an FDA 510(k) clearance for the BOSWORTH COPALIONER. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 176 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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

FDA 510(k) Submission Details - K933505

510(k) Number K933505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1993
Decision Date January 07, 1994
Days to Decision 176 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 127d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LBH Varnish, Cavity

All 93
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K933505.
ULTRACID DISINFECTING SOLOUTION
K953167 · Ultradent Products, Inc. · Sep 1995
ULTRACID F DISINFECTING SOLUTION
K953168 · Ultradent Products, Inc. · Sep 1995
FLUOR PROTECTOR
K946032 · Ivoclar North America, Inc. · Mar 1995
CONSEPSIS SCRUB
K925375 · Ultradent Products, Inc. · Jul 1993
CONSEPSIS(TM)
K924982 · Ultradent Products, Inc. · Jul 1993
DENTIN PROTECTOR
K901915 · Ivoclar North America, Inc. · Jun 1990