Cleared Traditional

K930939 - REBARON LC

K930939 is an FDA 510(k) clearance for REBARON LC, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K930939 · GC America, Inc. · Dental device
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Jan 1994
Decision
332d
Days
Class 2
Risk

K930939 is an FDA 510(k) clearance for the REBARON LC. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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. Elevated predicate reliance profile. 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 - K930939

510(k) Number K930939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date January 21, 1994
Days to Decision 332 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
205d slower than avg
Panel avg: 127d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 239
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K930939.
HARRY J. BOSWORTH RESIN I.
K946317 · Harry J. Bosworth Co. · Feb 1995
COE-SOFT LC
K940565 · GC America, Inc. · May 1994
KOOLINER II
K935261 · GC America, Inc. · Jan 1994
ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER
K934248 · Wallace A. Erickson & Co. · Dec 1993
DUAL CURE RELINE MATERIAL
K926406 · Dentsply Intl. · Mar 1993
PALABOND
K924422 · Heraeus Kulzer, Inc. · Nov 1992