Cleared Traditional

K942993 - THERMORESIN LC II

K942993 is an FDA 510(k) clearance for THERMORESIN LC II, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K942993 · GC America, Inc. · Dental device
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Feb 1995
Decision
232d
Days
Class 2
Risk

K942993 is an FDA 510(k) clearance for the THERMORESIN LC II. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 232 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 GC America, Inc. devices

FDA 510(k) Submission Details - K942993

510(k) Number K942993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date February 07, 1995
Days to Decision 232 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
105d slower than avg
Panel avg: 127d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K942993.
AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL
K951426 · American Dental Products, Inc. · May 1995
PERMASEAL
K950859 · Ultradent Products, Inc. · Mar 1995
DYRACT II RESTORATIVE
K950991 · Dentsply Intl. · Mar 1995
CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE
K946307 · Confi-Dental Products Co. · Jan 1995
OPTIGUARD
K945539 · Sybron Dental Specialties, Inc. · Dec 1994
TOTAL ETCH GEL
K945769 · Dentsply Intl. · Dec 1994