The following data is part of a premarket notification filed by Elos Medtech Pinol A/s with the FDA for Elos Accurate Customized Abutment, Elos Prosthetic Screw.
| Device ID | K171799 |
| 510k Number | K171799 |
| Device Name: | Elos Accurate Customized Abutment, Elos Prosthetic Screw |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Elos Medtech Pinol A/S Engvej 33 Goerloese, DK Dk-3330 |
| Contact | Tina Friis Poulsen |
| Correspondent | Tina Friis Poulsen Elos Medtech Pinol A/S Engvej 33 Goerloese, DK Dk-3330 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-16 |
| Decision Date | 2018-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712821002679 | K171799 | 000 |
| 05712821002655 | K171799 | 000 |
| 05712821002594 | K171799 | 000 |
| 05712821001917 | K171799 | 000 |
| 05712821001900 | K171799 | 000 |
| 05712821001894 | K171799 | 000 |