Cleared Traditional

ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E

K101485 · Bisco, Inc. · Dental
Aug 2010
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K101485 is an FDA 510(k) clearance for the ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 26, 2010, 90 days after receiving the submission on May 28, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K101485 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2010
Decision Date August 26, 2010
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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