The following data is part of a premarket notification filed by Dyna Dental Engineering Bv with the FDA for Dyna Implant Design.
| Device ID | K930868 |
| 510k Number | K930868 |
| Device Name: | DYNA IMPLANT DESIGN |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DYNA DENTAL ENGINEERING BV HOOFDAFDELING EXPORTBEVORDERIN EN ECONOMISCHE SAMENWERKING 2594 Ac Den Haag-holland, NU |
| Contact | De Nieuport |
| Correspondent | De Nieuport DYNA DENTAL ENGINEERING BV HOOFDAFDELING EXPORTBEVORDERIN EN ECONOMISCHE SAMENWERKING 2594 Ac Den Haag-holland, NU |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-19 |
| Decision Date | 1995-04-28 |