The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Air-flow Plus Prophylaxis Powder.
| Device ID | K171189 |
| 510k Number | K171189 |
| Device Name: | AIR-FLOW PLUS Prophylaxis Powder |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | E.M.S. Electro Medical Systems S.A. Chemin De La Vuarpilliere 31 Nyon, CH Ch-1260 |
| Contact | Suzanne Fassio-hardy |
| Correspondent | Christina Henza Can-Do-Medical Mundelein, IL 60060 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-24 |
| Decision Date | 2017-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353157173 | K171189 | 000 |
| 07613353157159 | K171189 | 000 |
| 07613353154127 | K171189 | 000 |
| 07613353154103 | K171189 | 000 |
| 07613353032043 | K171189 | 000 |
| 07613353197261 | K171189 | 000 |
| 07613353208264 | K171189 | 000 |
| 07613353206284 | K171189 | 000 |