K171189 is an FDA 510(k) clearance for the AIR-FLOW PLUS Prophylaxis powder. This device is classified as a Agent, Polishing, Abrasive, Oral Cavity (Class I - General Controls, product code EJR).
Submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on September 11, 2017, 140 days after receiving the submission on April 24, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6030.
| 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 |
| Product Code | EJR — Agent, Polishing, Abrasive, Oral Cavity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6030 |