Cleared Traditional

K112046 - MTA ANGELUS

K112046 is an FDA 510(k) clearance for MTA ANGELUS, manufactured by Angelus Industria DE Productos Odontologicos. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K112046 · Angelus Industria DE Productos Odontologicos · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
172d
Days
Class 2
Risk

K112046 is an FDA 510(k) clearance for the MTA ANGELUS. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Angelus Industria DE Productos Odontologicos (San Diego, US). The FDA issued a Cleared decision on January 6, 2012 after a review of 172 days - an extended review 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: 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.

FDA 510(k) Submission Details - K112046

510(k) Number K112046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2011
Decision Date January 06, 2012
Days to Decision 172 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
44d slower than avg
Panel avg: 128d · This submission: 172d
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 141
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K112046.
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