Cleared Traditional

ENCORE BOND

K971121 · Centrix, Inc. · Dental
Jun 1997
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K971121 is an FDA 510(k) clearance for the ENCORE BOND, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on June 27, 1997, 92 days after receiving the submission on March 27, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K971121 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1997
Decision Date June 27, 1997
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200