The following data is part of a premarket notification filed by Dentalplus Gmbh with the FDA for Dentalos Plus Mono, Dentalos Plus Multicolor.
| Device ID | K152215 |
| 510k Number | K152215 |
| Device Name: | DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DENTALPLUS GMBH KOHLGRUB 5 Samerberg, DE 83122 |
| Contact | Ralf Gerschuetz Rueth |
| Correspondent | Ralf Gerschuetz Rueth DENTALPLUS GMBH KOHLGRUB 5 Samerberg, DE 83122 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2016-01-19 |
| Summary: | summary |