Cleared Traditional

K930116 - LCL 8 (FDA 510(k) Clearance)

K930116 · Voco GmbH · Dental device

Jun 1993

Decision

157d

Days

Class 2

Risk

K930116 is an FDA 510(k) clearance for the LCL 8. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Voco GmbH (St Louis, US). The FDA issued a Cleared decision on June 17, 1993, 157 days after receiving the submission on January 11, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K930116 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 11, 1993
Decision Date	June 17, 1993
Days to Decision	157 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement