Cleared Traditional

K132478 - AIR-FLOW HANDY 3.0

K132478 is an FDA 510(k) clearance for AIR-FLOW HANDY 3.0, manufactured by E.M.S Electro Medical Systems S.A. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K132478 · E.M.S Electro Medical Systems S.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
246d
Days
Class 1
Risk

K132478 is an FDA 510(k) clearance for the AIR-FLOW HANDY 3.0. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by E.M.S Electro Medical Systems S.A (Marlborough, US). The FDA issued a Cleared decision on April 11, 2014 after a review of 246 days - an extended review cycle.

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. Standard predicate reliance. 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 E.M.S Electro Medical Systems S.A devices

FDA 510(k) Submission Details - K132478

510(k) Number K132478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2013
Decision Date April 11, 2014
Days to Decision 246 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
119d slower than avg
Panel avg: 127d · This submission: 246d
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 162
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