Cleared Traditional

K993545 - TENAX WHITE POST

K993545 is an FDA 510(k) clearance for TENAX WHITE POST, manufactured by Coltene/Whaledent, Inc.. The device is a Class 1 Dental device with product code ELR cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K993545 · Coltene/Whaledent, Inc. · Dental device
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Apr 2000
Decision
178d
Days
Class 1
Risk

K993545 is an FDA 510(k) clearance for the TENAX WHITE POST. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 178 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 Coltene/Whaledent, Inc. devices

FDA 510(k) Submission Details - K993545

510(k) Number K993545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1999
Decision Date April 14, 2000
Days to Decision 178 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
51d slower than avg
Panel avg: 127d · This submission: 178d
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 15
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K993545.
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
PARAPOST FIBER WHITE
K000311 · Coltene/Whaledent, Inc. · Mar 2000
FIBREKOR POST SYSTEM
K983266 · Jeneric/Pentron, Inc. · Nov 1998
COSMOPOST
K972875 · Ivoclar North America, Inc. · Sep 1997