The following data is part of a premarket notification filed by Dental Direkt Of Amerika Ug (haftungsbeschraenkt) with the FDA for Dd Bio Z, Dd Bio Zx(square), Dd Biozx(square) Color.
| Device ID | K142987 |
| 510k Number | K142987 |
| Device Name: | DD Bio Z, DD Bio ZX(square), DD BioZX(square) Color |
| Classification | Powder, Porcelain |
| Applicant | DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) PAPPELWEG 6 Spenge, DE 32139 |
| Contact | Gerhard De Boer |
| Correspondent | Uwe Greitens Dental Direkt GmbH Industriezentrum 103-108 Spenge, DE 32139 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-16 |
| Decision Date | 2015-02-11 |
| Summary: | summary |