The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Astra Tech Implants - Dental System: New Fixtures (micromacro).
| Device ID | K991053 |
| 510k Number | K991053 |
| Device Name: | ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO) |
| 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 | 1999-03-30 |
| Decision Date | 1999-06-25 |
| Summary: | summary |