Cleared Traditional

K964174 - MINERAL TRIOXIDE AGGREGATE (MTA)

K964174 is an FDA 510(k) clearance for MINERAL TRIOXIDE AGGREGATE (MTA), manufactured by Tulsa Dental Products, Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 115-day FDA review.

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

FDA 510(k) Submission Details - K964174

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.

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 96
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K964174.
SEALAPEX
K972369 · Sybron Dental Specialties, Inc. · Aug 1997
ENDO-SEAL
K971899 · Ultradent Products, Inc. · Jun 1997
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
K971622 · Mpl Technologies, Inc. · Jun 1997
ALPHA-DENT ROOT CANAL SEALER & FILLER
K963922 · Wallace A. Erickson & Co. · Dec 1996
AH PLUS ROOT CANAL SEALER
K960548 · Dentsply Intl. · Apr 1996
CANAL KING (THIN) CANAL KING (THICK)
K940368 · Pulpdent Corp. · Jan 1995