The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Atlantis Isus Implant Suprastructures.
| Device ID | K160207 |
| 510k Number | K160207 |
| Device Name: | ATLANTIS ISUS Implant Suprastructures |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-28 |
| Decision Date | 2016-09-21 |
| Summary: | summary |