Cleared Traditional

K875313 - PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST (FDA 510(k) Clearance)

K875313 · Bisco, Inc. · Dental device

Mar 1988

Decision

72d

Days

Class 2

Risk

K875313 is an FDA 510(k) clearance for the PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Bisco, Inc. (Downers Grove, US). The FDA issued a Cleared decision on March 10, 1988, 72 days after receiving the submission on December 29, 1987.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K875313 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 29, 1987
Decision Date	March 10, 1988
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—