The following data is part of a premarket notification filed by Astra Tech Ab with the FDA for Astra Tech Implant System.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ASTRA TECH IMPLANT SYSTEM 79029738 3280223 Live/Registered |
Dentsply IH AB 2005-12-08 |