Cleared Traditional

K011009 - WHITE MTA MATERIAL

K011009 is an FDA 510(k) clearance for WHITE MTA MATERIAL, manufactured by Dentsply International. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K011009 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
28d
Days
Class 2
Risk

K011009 is an FDA 510(k) clearance for the WHITE MTA MATERIAL. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on May 2, 2001 after a review of 28 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 International devices

FDA 510(k) Submission Details - K011009

510(k) Number K011009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2001
Decision Date May 02, 2001
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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 83
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K011009.
PULPDENT CALCIUM HYDROXIDE PREPARATION
K022734 · Pulpdent Corporation · Oct 2002
FIRST FILL R.C.S.
K011748 · Jeneric/Pentron, Inc. · Aug 2001
SEALAPEX 4
K010940 · Sybron Dental Specialties, Inc. · Jun 2001
ENDOREZ
K992097 · Ultradent Products, Inc. · Oct 1999
MTA MATERIAL II
K981620 · Dentsply Intl. · Jul 1998
MTA MATERIAL
K980332 · Dentsply Intl. · Feb 1998