The following data is part of a premarket notification filed by Dentsply Implant with the FDA for Atlantis Straumann Bone Level Abutment.
| Device ID | K130216 |
| 510k Number | K130216 |
| Device Name: | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | DENTSPLY IMPLANT 12264 EL CAMINO REAL SUITE 400 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz DENTSPLY IMPLANT 12264 EL CAMINO REAL SUITE 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-05-01 |
| Summary: | summary |