The following data is part of a premarket notification filed by Elos Medtech Pinol A/s with the FDA for Elos Accurate Customized Abutment.
| Device ID | K192457 |
| 510k Number | K192457 |
| Device Name: | Elos Accurate Customized Abutment |
| 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 | 2019-09-09 |
| Decision Date | 2020-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712821003010 | K192457 | 000 |
| 05712821002990 | K192457 | 000 |
| 05712821002976 | K192457 | 000 |
| 05712821002891 | K192457 | 000 |
| 05712821001986 | K192457 | 000 |
| 05712821001955 | K192457 | 000 |