Cleared Traditional

K092289 - EMS AIR-FLOW HANDY PERIO

K092289 is an FDA 510(k) clearance for EMS AIR-FLOW HANDY PERIO, 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 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

FDA 510(k) Submission Details - K092289

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
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 163
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K092289.
AIR-N-GO
K110379 · Satelec · Dec 2011
BOSWORTH AIR POLISHER
K100731 · Harry J. Bosworth Co. · Dec 2010
CENTURY MODEL 105C
K093341 · Sybron Dental Specialties, Inc. · Apr 2010
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · J. Morita USA, Inc. · Oct 2009
CONTRA-ANGLE HANDPIECE KOMET OS30
K090548 · W&H Dentalwerk Buermoos GmbH · Jun 2009
EMS AIR-FLOW MASTER
K082791 · E.M.S Electro Medical Systems S.A · Feb 2009