Cleared Traditional

K151047 - MTA Repair HP

K151047 is an FDA 510(k) clearance for MTA Repair HP, 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 499-day FDA review.

K151047 · Angelus Industria DE Productos Odontologicos · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
499d
Days
Class 2
Risk

K151047 is an FDA 510(k) clearance for the MTA Repair HP. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Angelus Industria DE Productos Odontologicos (Londrina, Pr, BR). The FDA issued a Cleared decision on August 31, 2016 after a review of 499 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Angelus Industria DE Productos Odontologicos devices

FDA 510(k) Submission Details - K151047

510(k) Number K151047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date August 31, 2016
Days to Decision 499 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
372d slower than avg
Panel avg: 127d · This submission: 499d
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 92
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K151047.
ENDOSOLV
K172839 · Septodont · Feb 2018
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018
Well-Root ST
K170950 · Vericom Co., Ltd. · Dec 2017
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · Dentsply International, Inc. · Feb 2015
REALSEAL XT SEALER
K102163 · Kerr Corporation · Oct 2010
WELL-PASTE
K090992 · Vericom Co., Ltd. · Apr 2009