The following data is part of a premarket notification filed by Dental Direkt Gmbh with the FDA for Dd Cube One Ml.
| Device ID | K183569 |
| 510k Number | K183569 |
| Device Name: | DD Cube ONE ML |
| Classification | Powder, Porcelain |
| Applicant | Dental Direkt GmbH Industriezentrum 106-108 Spenge, DE 32139 |
| Contact | Uwe Greitens |
| Correspondent | Vera Escher 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 | 2018-12-21 |
| Decision Date | 2019-02-14 |
| Summary: | summary |