Cleared Traditional

D/SENSE II (GREEN-OR) DENTIN DESENSITIZER

K992629 · Centrix, Inc. · Dental
Oct 1999
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K992629 is an FDA 510(k) clearance for the D/SENSE II (GREEN-OR) DENTIN DESENSITIZER, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on October 22, 1999, 86 days after receiving the submission on July 28, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K992629 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1999
Decision Date October 22, 1999
Days to Decision 86 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

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