Cleared Traditional

K101485 - ALL-ETCH, ALL- ETCH WITH BAC (FDA 510(k) Clearance)

Also includes:

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

K101485 · Bisco, Inc. · Dental device

Aug 2010

Decision

90d

Days

Class 2

Risk

K101485 is an FDA 510(k) clearance for the ALL-ETCH, ALL- ETCH WITH BAC. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K101485 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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