Cleared Traditional

K102808 - MI VARNISH (FDA 510(k) Clearance)

K102808 · GC America, Inc. · Dental device
Dec 2010
Decision
85d
Days
Class 2
Risk

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

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on December 22, 2010, 85 days after receiving the submission on September 28, 2010.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.

Submission Details

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

Device Classification

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