Cleared Traditional

K122892 - MTA2 ROOT AND PULP MATERIALS

K122892 is an FDA 510(k) clearance for MTA2 ROOT AND PULP MATERIALS, manufactured by Avalon Biomed, Inc.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K122892 · Avalon Biomed, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
82d
Days
Class 2
Risk

K122892 is an FDA 510(k) clearance for the MTA2 ROOT AND PULP MATERIALS. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Avalon Biomed, Inc. (Bradenton, US). The FDA issued a Cleared decision on December 11, 2012 after a review of 82 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.

FDA 510(k) Submission Details - K122892

510(k) Number K122892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2012
Decision Date December 11, 2012
Days to Decision 82 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
46d faster than avg
Panel avg: 128d · This submission: 82d
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 K122892.
MM-SEAL
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MTA CEMENTS
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MTA-FILLAPEX
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DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
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ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
K112078 · Maruchi · Mar 2012