Cleared Traditional

K013802 - FRC POSTEC

K013802 is an FDA 510(k) clearance for FRC POSTEC, manufactured by Ivoclar Vivadent, Inc.. The device is a Class 1 Dental device with product code ELR cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K013802 · Ivoclar Vivadent, Inc. · Dental device
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May 2002
Decision
167d
Days
Class 1
Risk

K013802 is an FDA 510(k) clearance for the FRC POSTEC. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on May 1, 2002 after a review of 167 days - an extended review cycle.

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.

View all Ivoclar Vivadent, Inc. devices

FDA 510(k) Submission Details - K013802

510(k) Number K013802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2001
Decision Date May 01, 2002
Days to Decision 167 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 127d · This submission: 167d
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 19
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K013802.
FRC POSTEC PLUS
K042848 · Ivoclar Vivadent, Inc. · Nov 2004
CARBON POST
K012496 · J. Morita USA, Inc. · May 2002
GLASS POST
K012849 · J. Morita USA, Inc. · Mar 2002
TENAX WHITE POST
K993545 · Coltene/Whaledent, Inc. · Apr 2000
PARAPOST FIBER WHITE
K000311 · Coltene/Whaledent, Inc. · Mar 2000
FIBREKOR POST SYSTEM
K983266 · Jeneric/Pentron, Inc. · Nov 1998