Cleared Traditional

K102808 - MI VARNISH

K102808 is an FDA 510(k) clearance for MI VARNISH, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K102808 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
85d
Days
Class 2
Risk

K102808 is an FDA 510(k) clearance for the MI VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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 - K102808

510(k) Number K102808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2010
Decision Date December 22, 2010
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 - LBH Varnish, Cavity

All 99
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K102808.
ACTIV VARNISH
K112946 · Pulpdent Corporation · Dec 2011
COLGATE DESENSITIZING DENTAL CREAM
K103461 · Colgate-Palmolive Co. · Sep 2011
NUPRO MODEL 13016901
K103160 · CAO Group, Inc. · Jan 2011
TOKUYAMA SHIELD FORCE
K100172 · Tokuyama Dental Corporation · Oct 2010
ASCENT F-COAT MODEL: 006-00097
K100540 · CAO Group, Inc. · Sep 2010
PULPDENT COPAL VARNISH WITH FLUORIDE
K100503 · Pulpdent Corporation · May 2010