Cleared Traditional

K123276 - MM-SEAL

K123276 is the FDA 510(k) clearance for MM-SEAL by Micro-Mega Societe Anonyme. It is a Class 2 Dental device (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)
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.

View all Micro-Mega Societe Anonyme devices

Submission Details

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
Regulatory Context
Review time vs. panel average
380d slower than avg
Panel avg: 127d · This submission: 507d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 73
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K123276.
ENDOSEAL MTA
K170175 · Maruchi · Feb 2018
ENDOSOLV
K172839 · Septodont · Feb 2018
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
ENDOREZ
K042756 · Ultradent Products, Inc. · Oct 2004
DIAPEX
K033585 · Bisco, Inc. · Jan 2004