Cleared Traditional

K020431 - FIBIOCORE
(FDA 510(k) Clearance)

K020431 · Est. Anthogyr · Dental device

Jul 2002

Decision

145d

Days

Class 1

Risk

K020431 is an FDA 510(k) clearance for the FIBIOCORE. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).

Submitted by Est. Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on July 3, 2002, 145 days after receiving the submission on February 8, 2002.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3810.

Submission Details

510(k) Number	K020431 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 08, 2002
Decision Date	July 03, 2002
Days to Decision	145 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF