The following data is part of a premarket notification filed by Astra Meditec Ab with the FDA for Astra Dental Implant System.
| Device ID | K882578 |
| 510k Number | K882578 |
| Device Name: | ASTRA DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ASTRA MEDITEC AB P.O. BOX 14 S-4321 21 MOLNDAL Sweden, SE |
| Contact | Anders Holmen |
| Correspondent | Anders Holmen ASTRA MEDITEC AB P.O. BOX 14 S-4321 21 MOLNDAL Sweden, SE |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-22 |
| Decision Date | 1988-08-12 |