Cleared Traditional

K992097 - ENDOREZ

K992097 is the FDA 510(k) clearance for ENDOREZ by Ultradent Products, Inc.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K992097 · Ultradent Products, Inc. · Dental device
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Oct 1999
Decision
127d
Days
Class 2
Risk

K992097 is an FDA 510(k) clearance for the ENDOREZ. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 26, 1999 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K992097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1999
Decision Date October 26, 1999
Days to Decision 127 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
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KIF Resin, Root Canal Filling

All 74
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K992097.
DIAPEX
K033585 · Bisco, Inc. · Jan 2004
FIRST FILL R.C.S.
K011748 · Jeneric/Pentron, Inc. · Aug 2001
SEALAPEX 4
K010940 · Sybron Dental Specialties, Inc. · Jun 2001
MTA MATERIAL II
K981620 · Dentsply Intl. · Jul 1998
MTA MATERIAL
K980332 · Dentsply Intl. · Feb 1998
SEALAPEX
K972369 · Sybron Dental Specialties, Inc. · Aug 1997