The following data is part of a premarket notification filed by Dental Direkt Gmbh with the FDA for Dd Cubex2.
| Device ID | K150196 |
| 510k Number | K150196 |
| Device Name: | DD CubeX2 |
| Classification | Powder, Porcelain |
| Applicant | DENTAL DIREKT GMBH INDUSTRIEZENTRUM 106-108 Spenge, DE 32139 |
| Contact | Uwe Greitens |
| Correspondent | Uwe Greitens DENTAL DIREKT GMBH INDUSTRIEZENTRUM 106-108 Spenge, DE 32139 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-29 |
| Decision Date | 2015-03-26 |
| Summary: | summary |