Cleared Traditional

K980332 - MTA MATERIAL

K980332 is an FDA 510(k) clearance for MTA MATERIAL, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K980332 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
27d
Days
Class 2
Risk

K980332 is an FDA 510(k) clearance for the MTA MATERIAL. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on February 24, 1998 after a review of 27 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Intl. devices

FDA 510(k) Submission Details - K980332

510(k) Number K980332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1998
Decision Date February 24, 1998
Days to Decision 27 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 127d · This submission: 27d
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 130
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K980332.
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
VITAPEX PRE-LOADED DENTAL SYRINGE
K973667 · Neodental Chemical Products Co., Ltd. · Nov 1997
SEALAPEX
K972369 · Sybron Dental Specialties, Inc. · Aug 1997
ENDO-SEAL
K971899 · Ultradent Products, Inc. · Jun 1997