Cleared Traditional

AIR-N-GO (K110379) - FDA 510(k) Clearance

Class I Dental device.

K110379 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 127d · This submission: 301d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 37
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K110379.
Dental High-speed Handpiece and Accessories
K173943 · Microp Technology (Taiwan), Inc. · Jul 2018
High-speed Turbine Handpieces for Single Use
K172543 · Beijing Dongbo Dental Handpiece Co., Ltd. · Jul 2018
Concentrix MX-AC High-Speed Handpiece
K173465 · Dentalez, Inc. · Mar 2018
DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
K041141 · Dentsply Intl. · Jun 2004
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145 · Dentsply Intl. · Jul 2003
TULSA CONTRA ANGLES
K012720 · Dentsply Intl. · Nov 2001