Cleared Traditional

VERSAETCH

K973257 · Centrix, Inc. · Dental
Nov 1997
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K973257 is an FDA 510(k) clearance for the VERSAETCH, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on November 17, 1997, 80 days after receiving the submission on August 29, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K973257 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1997
Decision Date November 17, 1997
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690