Cleared Traditional

K933206 - EXA BITE REGISTRATION MATERIAL

K933206 is the FDA 510(k) clearance for EXA BITE REGISTRATION MATERIAL by GC America, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K933206 · GC America, Inc. · Dental device
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Sep 1993
Decision
90d
Days
Class 2
Risk

K933206 is an FDA 510(k) clearance for the EXA BITE REGISTRATION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on September 29, 1993 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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

Submission Details

510(k) Number K933206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1993
Decision Date September 29, 1993
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 140
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K933206.
HYDROCOLLOID HEATING UNIT
K935151 · Centrix, Inc. · Apr 1994
SUPERGEL/SUPPRESSED DUST
K940402 · Harry J. Bosworth Co. · Mar 1994
EXTRUDE
K940379 · Sybron Dental Specialties, Inc. · Mar 1994
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993
VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD
K926033 · Harry J. Bosworth Co. · May 1993
TRIANGULAR JAW MICROLARYNGEAL FORCEPS
K925370 · Pilling Co. · Mar 1993