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
Download Printable Device Report (PDF)
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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
173d slower than avg
Panel avg: 128d · 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 204
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K110379.
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
K113301 · Dentalez, Inc. · Jan 2012
AIRLIGHT DENTAL HANDPIECE
K112623 · Beyes Dental Canada, Inc. · Dec 2011
EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
K112869 · Beyes Dental Canada, Inc. · Dec 2011
TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
K102517 · Thunder Tiger Corp. · Apr 2011
BOSWORTH AIR POLISHER
K100731 · Harry J. Bosworth Co. · Dec 2010
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
K101551 · Delma Medical Instrument (Guangzhou) Co., Ltd. · Sep 2010