Cleared Traditional

K942993 - THERMORESIN LC II (FDA 510(k) Clearance)

K942993 · GC America, Inc. · Dental device

Feb 1995

Decision

232d

Days

Class 2

Risk

K942993 is an FDA 510(k) clearance for the THERMORESIN LC II. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on February 7, 1995, 232 days after receiving the submission on June 20, 1994.

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

Submission Details

510(k) Number	K942993 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 20, 1994
Decision Date	February 07, 1995
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement