ASTRA TECH IMPLANT SYSTEM
Implant, Endosseous, Root-form
ASTRA TECH AB
The following data is part of a premarket notification filed by Astra Tech Ab with the FDA for Astra Tech Implant System.
Pre-market Notification Details
| Device ID | K111287 |
| 510k Number | K111287 |
| Device Name: | ASTRA TECH IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-06 |
| Decision Date | 2011-09-26 |
| Summary: | summary |
Trademark Results [ASTRA TECH IMPLANT SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASTRA TECH IMPLANT SYSTEM 79029738 3280223 Live/Registered |
Dentsply IH AB 2005-12-08 |
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