Cleared Traditional

K042848 - FRC POSTEC PLUS

K042848 is the FDA 510(k) clearance for FRC POSTEC PLUS by Ivoclar Vivadent, Inc.. It is a Class 1 Dental device (product code ELR) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K042848 · Ivoclar Vivadent, Inc. · Dental device
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Nov 2004
Decision
38d
Days
Class 1
Risk

K042848 is an FDA 510(k) clearance for the FRC POSTEC PLUS. 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 November 22, 2004 after a review of 38 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K042848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2004
Decision Date November 22, 2004
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 10
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K042848.
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
FIBREKOR POST SYSTEM
K983266 · Jeneric/Pentron, Inc. · Nov 1998
COSMOPOST
K972875 · Ivoclar North America, Inc. · Sep 1997
C-POST
K945370 · Bisco, Inc. · Mar 1995