Cleared Traditional

K926238 - BISCO PORCELAIN ETCHING GEL (FDA 510(k) Clearance)

K926238 · Bisco, Inc. · Dental device

Mar 1993

Decision

110d

Days

Class 2

Risk

K926238 is an FDA 510(k) clearance for the BISCO PORCELAIN ETCHING GEL. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on March 31, 1993, 110 days after receiving the submission on December 11, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K926238 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 11, 1992
Decision Date	March 31, 1993
Days to Decision	110 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement