Cleared Traditional

MINERAL TRIOXIDE AGGREGATE (MTA) (K964174) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964174 · Tulsa Dental Products, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
115d
Days
Class 2
Risk

K964174 is an FDA 510(k) clearance for the MINERAL TRIOXIDE AGGREGATE (MTA). Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Tulsa Dental Products, Ltd. (Bethesda, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 115 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 Tulsa Dental Products, Ltd. devices

Submission Details

510(k) Number K964174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1996
Decision Date February 10, 1997
Days to Decision 115 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 127d · This submission: 115d
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 59
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K964174.
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018
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MTA MATERIAL
K980332 · Dentsply Intl. · Feb 1998
AH PLUS ROOT CANAL SEALER
K960548 · Dentsply Intl. · Apr 1996
ROOT CANAL FILLING RESIN
K854253 · Dentsply Intl. · Dec 1985
ROOT CANAL FILLING RESIN
K820284 · Dentsply Intl. · Mar 1982