Cleared Traditional

K092289 - EMS AIR-FLOW HANDY PERIO

K092289 is the FDA 510(k) clearance for EMS AIR-FLOW HANDY PERIO by E.M.S Electro Medical Systems S.A. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K092289 · E.M.S Electro Medical Systems S.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
83d
Days
Class 1
Risk

K092289 is an FDA 510(k) clearance for the EMS AIR-FLOW HANDY PERIO. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by E.M.S Electro Medical Systems S.A (North Attleboro, US). The FDA issued a Cleared decision on October 20, 2009 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all E.M.S Electro Medical Systems S.A devices

Submission Details

510(k) Number K092289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date October 20, 2009
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
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 78
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K092289.
PROPHY-MATE NEO
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CENTURY MODEL 105C
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AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · J. Morita USA, Inc. · Oct 2009
CARE3 PLUS
K081811 · Nakanishi, Inc. · Jan 2009
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
K082716 · A-Dec, Inc. · Jan 2009