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 |