The following data is part of a premarket notification filed by Astra Tech Ab with the FDA for Osseospeed Plus.
Device ID | K120414 |
510k Number | K120414 |
Device Name: | OSSEOSPEED PLUS |
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 | 2012-02-10 |
Decision Date | 2012-07-31 |
Summary: | summary |