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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
371d slower than avg
Panel avg: 128d · 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 Consultant

Techlink International
Lilian Llull

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K151047.
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