Cleared Traditional

K012542 - REVOTEK LC

K012542 is an FDA 510(k) clearance for REVOTEK LC, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K012542 · GC America, Inc. · Dental device
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Oct 2001
Decision
70d
Days
Class 2
Risk

K012542 is an FDA 510(k) clearance for the REVOTEK LC. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 16, 2001 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 GC America, Inc. devices

FDA 510(k) Submission Details - K012542

510(k) Number K012542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date October 16, 2001
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 104
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K012542.
ADMIRA SEAL
K021842 · Voco GmbH · Jul 2002
ADMIRA PROTECT
K021844 · Voco GmbH · Jul 2002
DENTITION INTEGRATING MATERIAL
K020287 · Pulpdent Corporation · Apr 2002
TEETHMATE F-1
K012742 · Kuraray Medical, Inc. · Sep 2001
OPTIBOND SOLO PLUS 3
K011908 · Kerr Dental Materials Center · Sep 2001
HELIOSEAL CLEAR CHROMA
K011491 · Ivoclar North America, Inc. · Aug 2001