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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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
50d slower than avg
Panel avg: 128d · 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 31
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K993545.
SNOWPOST, SNOWLIGHT
K012354 · Danville Materials, Inc. · Oct 2001
HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
K003219 · Harald Nordin S.A · Oct 2000
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
K003221 · Harald Nordin S.A · Oct 2000
PARAPOST FIBER WHITE
K000311 · Coltene/Whaledent, Inc. · Mar 2000
FIBREKOR POST SYSTEM
K983266 · Jeneric/Pentron, Inc. · Nov 1998
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC
K983161 · Sabre-K , Ltd. · Sep 1998