Cleared Traditional

GLY-ETCH

K961190 · Centrix, Inc. · Dental
Apr 1996
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K961190 is an FDA 510(k) clearance for the GLY-ETCH, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on April 23, 1996, 28 days after receiving the submission on March 26, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K961190 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1996
Decision Date April 23, 1996
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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

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