Cleared Traditional

K020431 - FIBIOCORE

K020431 is an FDA 510(k) clearance for FIBIOCORE, manufactured by Est. Anthogyr. The device is a Class 1 Dental device with product code ELR cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K020431 · Est. Anthogyr · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
145d
Days
Class 1
Risk

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

Submitted by Est. Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on July 3, 2002 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3810 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K020431

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 128d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

ELR Device Classification - Class 1, General Controls

Product Code ELR Post, Root Canal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ELR Post, Root Canal

All 33
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K020431.
FIBER-METAL POST
K060075 · Foremost Dental, LLC · Mar 2006
FRC POSTEC PLUS
K042848 · Ivoclar Vivadent, Inc. · Nov 2004
EVERSTICK POST
K030820 · Stick Tech , Ltd. · May 2003
CARBON POST
K012496 · J. Morita USA, Inc. · May 2002
FRC POSTEC
K013802 · Ivoclar Vivadent, Inc. · May 2002
GLASS POST
K012849 · J. Morita USA, Inc. · Mar 2002
K020431 · FIBIOCORE
Download PDF FDA Summary Est. Anthogyr