Cleared Traditional

K861148 - BISCO'S PORCELAIN VENEER SYSTEM (FDA 510(k) Clearance)

K861148 · Bisco, Inc. · Dental device

Apr 1986

Decision

35d

Days

Class 2

Risk

K861148 is an FDA 510(k) clearance for the BISCO'S PORCELAIN VENEER SYSTEM. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Bisco, Inc. (Lombard, US). The FDA issued a Cleared decision on April 30, 1986, 35 days after receiving the submission on March 26, 1986.

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

Submission Details

510(k) Number	K861148 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 26, 1986
Decision Date	April 30, 1986
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—