Cleared Traditional

K110379 - AIR-N-GO

K110379 is an FDA 510(k) clearance for AIR-N-GO, manufactured by Satelec. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K110379 · Satelec · Dental device
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Dec 2011
Decision
301d
Days
Class 1
Risk

K110379 is an FDA 510(k) clearance for the AIR-N-GO. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Satelec (Mt. Laurel, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Satelec devices

FDA 510(k) Submission Details - K110379

510(k) Number K110379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2011
Decision Date December 08, 2011
Days to Decision 301 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
174d slower than avg
Panel avg: 127d · This submission: 301d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 90
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K110379.
TI-MAX X450
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K112673 · Nakanishi, Inc. · Feb 2012
BOSWORTH AIR POLISHER
K100731 · Harry J. Bosworth Co. · Dec 2010
CENTURY MODEL 105C
K093341 · Sybron Dental Specialties, Inc. · Apr 2010
EMS AIR-FLOW HANDY PERIO
K092289 · E.M.S Electro Medical Systems S.A · Oct 2009