Cleared Traditional

K892806 - TUF-COAT

K892806 is an FDA 510(k) clearance for TUF-COAT, manufactured by G-C Intl. Corp.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K892806 · G-C Intl. Corp. · Dental device
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Jul 1989
Decision
88d
Days
Class 2
Risk

K892806 is an FDA 510(k) clearance for the TUF-COAT. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by G-C Intl. Corp. (Scottsdale, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 - K892806

510(k) Number K892806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1989
Decision Date July 14, 1989
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELL Device Classification - Class 2, Special Controls

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 - ELL Teeth, Porcelain

All 29
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K892806.
SYSNPAR PORCELAIN
K910303 · Jeneric/Pentron, Inc. · Mar 1991
PROCERAM PORCELAIN
K903907 · Nobelpharma USA, Inc. · Nov 1990
DEN-MAT LAMI-QUICK
K895269 · Den-Mat Corp. · Feb 1990
CRYSTAR(TM) ANTI-GREENING LIQUID
K893481 · Shofu Dental Corp. · Jul 1989
CRYSTAR(TM) VINTAGE PORCELAIN
K884214 · Shofu Dental Corp. · Dec 1988
SPECTRUM
K880774 · Dentsply Intl. · May 1988