The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Astra Tech Implant Dental System.
| Device ID | K974737 |
| 510k Number | K974737 |
| Device Name: | ASTRA TECH IMPLANT DENTAL SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ASTRA TECH, INC. 430 BEDFORD ST. SUITE 100 Lexington, MA 02173 |
| Contact | Niklas Lidskog |
| Correspondent | Niklas Lidskog ASTRA TECH, INC. 430 BEDFORD ST. SUITE 100 Lexington, MA 02173 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-03-24 |
| Summary: | summary |