The following data is part of a premarket notification filed by Dentsply Implants Manufacturing Gmbh with the FDA for Osseospeed Profile Ev.
Device ID | K130999 |
510k Number | K130999 |
Device Name: | OSSEOSPEED PROFILE EV |
Classification | Implant, Endosseous, Root-form |
Applicant | DENTSPLY IMPLANTS MANUFACTURING GMBH 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
Contact | Linda K Schulz |
Correspondent | Linda K Schulz DENTSPLY IMPLANTS MANUFACTURING GMBH 12264 El Camino Real, Suite 400 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 | 2013-04-10 |
Decision Date | 2013-10-25 |
Summary: | summary |