The following data is part of a premarket notification filed by Dental Direkt Gmbh with the FDA for Dd Medical Polymers.
| Device ID | K153490 |
| 510k Number | K153490 |
| Device Name: | DD Medical Polymers |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DENTAL DIREKT GMBH INDUSTRIEZENTRUM 106-108 Spenge, DE 32139 |
| Contact | Uwe Greitens |
| Correspondent | Vera Buescher DENTAL DIREKT GMBH (FORMER DENTAL DIREKT OF AMERIKA UG) INDUSTRIEZENTRUM 106-108 Spenge, DE 32139 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-04 |
| Decision Date | 2016-05-13 |
| Summary: | summary |