The following data is part of a premarket notification filed by Deltamed Gmbh with the FDA for Extra-oral, Additive Computer Aided Manufacture And Curing System.
| Device ID | K102776 |
| 510k Number | K102776 |
| Device Name: | EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DELTAMED GMBH RAIFFEISENSTR. 8A Friedberg, DE D-61169 |
| Contact | Emanuel Mesaric |
| Correspondent | Emanuel Mesaric DELTAMED GMBH RAIFFEISENSTR. 8A Friedberg, DE D-61169 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-24 |
| Decision Date | 2011-02-18 |
| Summary: | summary |