The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Ems Air-flow Master.
| Device ID | K082791 |
| 510k Number | K082791 |
| Device Name: | EMS AIR-FLOW MASTER |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 49 PLAIN ST North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J Nolte E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 49 PLAIN ST North Attleboro, MA 02760 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2009-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353172336 | K082791 | 000 |
| 07613353055769 | K082791 | 000 |
| 07613353055745 | K082791 | 000 |
| 07613353055363 | K082791 | 000 |
| 07613353002763 | K082791 | 000 |
| 07613353002756 | K082791 | 000 |
| 07613353002749 | K082791 | 000 |
| 07613353001858 | K082791 | 000 |
| 07613353001841 | K082791 | 000 |
| 07613353055783 | K082791 | 000 |
| 07613353055790 | K082791 | 000 |
| 07613353060541 | K082791 | 000 |
| 07613353172329 | K082791 | 000 |
| 07613353167820 | K082791 | 000 |
| 07613353167813 | K082791 | 000 |
| 07613353126377 | K082791 | 000 |
| 07613353113049 | K082791 | 000 |
| 07613353077648 | K082791 | 000 |
| 07613353077631 | K082791 | 000 |
| 07613353061296 | K082791 | 000 |
| 07613353060510 | K082791 | 000 |