Cleared Traditional

K171189 - AIR-FLOW PLUS Prophylaxis powder

K171189 is an FDA 510(k) clearance for AIR-FLOW PLUS Prophylaxis powder, manufactured by E.M.S Electro Medical Systems S.A. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K171189 · E.M.S Electro Medical Systems S.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
140d
Days
Class 1
Risk

K171189 is an FDA 510(k) clearance for the AIR-FLOW PLUS Prophylaxis powder. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on September 11, 2017 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 - K171189

510(k) Number K171189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2017
Decision Date September 11, 2017
Days to Decision 140 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
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

EJR Device Classification - Class 1, General Controls

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
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 Consultant

Can-Do-Medical
Christina Henza

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EJR Agent, Polishing, Abrasive, Oral Cavity

All 37
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K171189.
WHIP MIX PREPPIES PLUS
K131760 · Whip-Mix Corp. · Mar 2014
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
K121698 · Dentsply International, Inc. · Aug 2012
REMIN PRO
K101104 · Voco GmbH · Oct 2010
GC MI PASTE PLUS
K070854 · GC America, Inc. · Apr 2007
ENAMEL PRO
K062166 · Premier Dental Products Co. · Nov 2006
GELATO PROPHYLAXIS PASTE
K042048 · Deepak Products, Inc. · Oct 2004