Cleared Traditional

K834363 - ENDIX RADICULAR BIOCERAMIC PIN
(FDA 510(k) Clearance)

K834363 · C.B.S. Biotechnics, Inc. · Dental device

Feb 1984

Decision

123d

Days

Class 2

Risk

K834363 is an FDA 510(k) clearance for the ENDIX RADICULAR BIOCERAMIC PIN. This device is classified as a Splint, Endodontic Stabilizing (Class II - Special Controls, product code ELS).

Submitted by C.B.S. Biotechnics, Inc. (Walker, US). The FDA issued a Cleared decision on February 27, 1984, 123 days after receiving the submission on October 27, 1983.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3890.

Submission Details

510(k) Number	K834363 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 27, 1983
Decision Date	February 27, 1984
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—