Cleared Traditional

K981972 - GREEN-OR DENTIN DESENSITIZER (FDA 510(k) Clearance)

K981972 · Centrix, Inc. · Dental device
Dec 1998
Decision
186d
Days
Class 2
Risk

K981972 is an FDA 510(k) clearance for the GREEN-OR DENTIN DESENSITIZER. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on December 7, 1998, 186 days after receiving the submission on June 4, 1998.

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

Submission Details

510(k) Number K981972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1998
Decision Date December 07, 1998
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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