Cleared Traditional

K081268 - SONIC AIR MM1500 + (MID), MODEL 50400014

K081268 is an FDA 510(k) clearance for SONIC AIR MM1500 + (MID), manufactured by Micro-Mega Societe Anonyme. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 462-day FDA review.

K081268 · Micro-Mega Societe Anonyme · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
462d
Days
Class 2
Risk

K081268 is an FDA 510(k) clearance for the SONIC AIR MM1500 + (MID), MODEL 50400014. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Micro-Mega Societe Anonyme (Besancon, FR). The FDA issued a Cleared decision on August 10, 2009 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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

FDA 510(k) Submission Details - K081268

510(k) Number K081268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date August 10, 2009
Days to Decision 462 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 127d · This submission: 462d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 - ELC Scaler, Ultrasonic

All 84
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K081268.
EMS MINIMASTER LED
K093723 · E.M.S Electro Medical Systems S.A · Sep 2010
EMS PIEZON MASTER 700
K093000 · E.M.S Electro Medical Systems S.A · Jul 2010
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
K100647 · A-Dec, Inc. · Jul 2010
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
K080089 · Sybron Dental Specialties, Inc. · Sep 2008
VARIOS 75
K071447 · Nakanishi, Inc. · Apr 2008
PERIOSCAN, MODEL: D 3496
K072107 · Sirona Dental Systems GmbH · Feb 2008