The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Tcm 3000 And Tcm Endo.
| Device ID | K981679 |
| 510k Number | K981679 |
| Device Name: | TCM 3000 AND TCM ENDO |
| 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 | 1998-05-13 |
| Decision Date | 1999-02-09 |
| Summary: | summary |