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 | K222044 |
| 510k Number | K222044 |
| Device Name: | Elos Accurate Customized Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Elos Medtech Pinol A/S Engvej 33 Goerloese, DK 3330 |
| Contact | Lise Terkelsen |
| Correspondent | Lise Terkelsen Elos Medtech Pinol A/S Engvej 33 Goerloese, 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 | 2022-07-11 |
| Decision Date | 2022-11-30 |