The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Astra Tech Implants - Dental System.
| Device ID | K041492 |
| 510k Number | K041492 |
| Device Name: | ASTRA TECH IMPLANTS - DENTAL SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ASTRA TECH, INC. 96 WEST MAIN ST. P.O. BOX 809 Northborough, MA 01532 |
| Contact | Bruce R Manning |
| Correspondent | Bruce R Manning ASTRA TECH, INC. 96 WEST MAIN ST. P.O. BOX 809 Northborough, MA 01532 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-04 |
| Decision Date | 2004-08-09 |
| Summary: | summary |