The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Md 10, Sem, Sm 12, Cbm.
| Device ID | K000710 |
| 510k Number | K000710 |
| Device Name: | MD 10, SEM, SM 12, CBM |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NOUVAG AG SUDETENSTR. 5 Kaufbeuren, DE D87600 |
| Contact | Margit Eschbaumer |
| Correspondent | Margit Eschbaumer NOUVAG AG SUDETENSTR. 5 Kaufbeuren, DE D87600 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-02 |
| Decision Date | 2000-05-11 |