Cleared Traditional

K132825 - RETROMTA-ORTHOMTA II

K132825 is an FDA 510(k) clearance for RETROMTA-ORTHOMTA II, manufactured by Biomta. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K132825 · Biomta · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
213d
Days
Class 2
Risk

K132825 is an FDA 510(k) clearance for the RETROMTA-ORTHOMTA II. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Biomta (Fullerton, US). The FDA issued a Cleared decision on April 10, 2014 after a review of 213 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 - K132825

510(k) Number K132825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2013
Decision Date April 10, 2014
Days to Decision 213 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
85d slower than avg
Panel avg: 128d · This submission: 213d
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 143
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K132825.
ENDOCEM ZR
K133042 · Maruchi · May 2014
ENDOSEAL
K133054 · Maruchi · May 2014
MTA FILLAPEX
K140247 · Angelus Industria DE Productos Odontologicos SA · Apr 2014
TRC-PASTE
K133716 · Km Corporation · Apr 2014
TRC-PEX, RADIC-SEALER
K132123 · Km Corporation · Mar 2014
MM-SEAL
K123276 · Micro-Mega Societe Anonyme · Mar 2014
K132825 · RETROMTA-ORTHOMTA II
Download PDF FDA Summary Biomta