Cleared Traditional

K992097 - ENDOREZ

K992097 is an FDA 510(k) clearance for ENDOREZ, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K992097

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.

KIF Device Classification - Class 2, Special Controls

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 124
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K992097.
SEALAPEX 4
K010940 · Sybron Dental Specialties, Inc. · Jun 2001
WHITE MTA MATERIAL
K011009 · Dentsply International · May 2001
THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM
K992727 · Mds · Jan 2000
ROEKO SEAL
K983037 · Roeko Ulm, Roescheisen GmbH & Co. · Oct 1998
MTA MATERIAL II
K981620 · Dentsply Intl. · Jul 1998
ENDOSOLV E
K980633 · Specialites Septodont · May 1998