Cleared Traditional

K921406 - SILICONT BUR BLOCK
(FDA 510(k) Clearance)

K921406 · Innovators, Inc. · Dental device

Apr 1992

Decision

39d

Days

Class 1

Risk

K921406 is an FDA 510(k) clearance for the SILICONT BUR BLOCK. This device is classified as a Bur, Dental (Class I - General Controls, product code EJL).

Submitted by Innovators, Inc. (Jefferson City, US). The FDA issued a Cleared decision on April 28, 1992, 39 days after receiving the submission on March 20, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3240.

Submission Details

510(k) Number	K921406 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 20, 1992
Decision Date	April 28, 1992
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement