Cleared Special

K073284 - AIR-FLOW MASTER STANDARD

K073284 is an FDA 510(k) clearance for AIR-FLOW MASTER STANDARD, manufactured by (Ems Sa) Electro Medical Systems. The device is a Class 1 Dental device with product code EFB cleared through the Special 510(k) pathway after a 23-day FDA review.

K073284 · (Ems Sa) Electro Medical Systems · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
23d
Days
Class 1
Risk

K073284 is an FDA 510(k) clearance for the AIR-FLOW MASTER STANDARD. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by (Ems Sa) Electro Medical Systems (North Attleboro, US). The FDA issued a Cleared decision on December 14, 2007 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all (Ems Sa) Electro Medical Systems devices

FDA 510(k) Submission Details - K073284

510(k) Number K073284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2007
Decision Date December 14, 2007
Days to Decision 23 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 118
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K073284.
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
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
K082827 · A-Dec, Inc. · Jan 2009
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
K073478 · Sybron Dental Specialties, Inc. · Sep 2008
I-SURGE
K071965 · Satelec · Sep 2007
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
K070663 · A-Dec, Inc. · Jul 2007
LUBRINA, MODEL HIM-1
K070074 · J. Morita USA, Inc. · May 2007