Cleared Traditional

K933206 - EXA BITE REGISTRATION MATERIAL

K933206 is an FDA 510(k) clearance for EXA BITE REGISTRATION MATERIAL, manufactured by GC America, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K933206

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.

ELW Device Classification - Class 2, Special Controls

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 306
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K933206.
ALPHA-DENT
K940120 · Wallace A. Erickson & Co. · Feb 1994
TREND SET 2 PLUS
K936070 · Confi-Dental Products Co. · Feb 1994
VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM
K930248 · Crown Delta Corp. · Jan 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