Cleared Traditional

K812406 - EXAFLEX IMPRESSION MATERIAL

K812406 is an FDA 510(k) clearance for EXAFLEX IMPRESSION MATERIAL, manufactured by G-C Intl. Corp.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K812406 · G-C Intl. Corp. · Dental device
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Oct 1981
Decision
46d
Days
Class 2
Risk

K812406 is an FDA 510(k) clearance for the EXAFLEX IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by G-C Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1981 after a review of 46 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all G-C Intl. Corp. devices

FDA 510(k) Submission Details - K812406

510(k) Number K812406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1981
Decision Date October 06, 1981
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 127d · This submission: 46d
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 201
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K812406.
PERFOURM
K842324 · Cutter Laboratories, Inc. · Nov 1984
ODONTIC CENTRIC(BITE) REGIST. PASTE
K830044 · Wallace A. Erickson & Co. · Apr 1983
SYBRON/KERR MIRROR 3
K820183 · Sybron Corp. · Feb 1982
G-C FIT-CHECKER IMPRESSION MATERIAL
K812679 · G-C Intl. Corp. · Oct 1981
SR-ALGICAP
K811867 · J. Aderer, Inc. · Oct 1981
SR-IVOSEAL
K810523 · J. Aderer, Inc. · Apr 1981