The following data is part of a premarket notification filed by Dental Direkt Of Amerika Ug (haftungsbeschraenkt) with the FDA for Dd Bio Z And Dd Bio Z - Transpa.
| Device ID | K093748 |
| 510k Number | K093748 |
| Device Name: | DD BIO Z AND DD BIO Z - TRANSPA |
| Classification | Powder, Porcelain |
| Applicant | DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) PAPPELWEG 6 Spenge, DE 32139 |
| Contact | Gerhard De Boer |
| Correspondent | Gerhard De Boer DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) PAPPELWEG 6 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 | 2009-12-04 |
| Decision Date | 2010-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024020306 | K093748 | 000 |
| 00889024018723 | K093748 | 000 |
| 00889024015593 | K093748 | 000 |
| 00889024014831 | K093748 | 000 |
| 00889024014541 | K093748 | 000 |
| 00889024014473 | K093748 | 000 |
| 00889024014404 | K093748 | 000 |