Cleared Traditional

K123276 - MM-SEAL

K123276 is an FDA 510(k) clearance for MM-SEAL, manufactured by Micro-Mega Societe Anonyme. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 507-day FDA review.

K123276 · Micro-Mega Societe Anonyme · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
507d
Days
Class 2
Risk

K123276 is an FDA 510(k) clearance for the MM-SEAL. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Micro-Mega Societe Anonyme (Besancon, FR). The FDA issued a Cleared decision on March 10, 2014 after a review of 507 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 - K123276

510(k) Number K123276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2012
Decision Date March 10, 2014
Days to Decision 507 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
379d slower than avg
Panel avg: 128d · This submission: 507d
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 K123276.
RETROMTA-ORTHOMTA II
K132825 · Biomta · Apr 2014
TRC-PASTE
K133716 · Km Corporation · Apr 2014
TRC-PEX, RADIC-SEALER
K132123 · Km Corporation · Mar 2014
BIOROOT RCS
K130601 · Novocol, Inc. · Oct 2013
MTA CEMENTS
K130125 · S&C Polymer Silicon- Und Composite Spezialitaeten · Jul 2013
MTA2 ROOT AND PULP MATERIALS
K122892 · Avalon Biomed, Inc. · Dec 2012
K123276 · MM-SEAL
Download PDF FDA Summary Micro-Mega Societe An…