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 | K191890 |
| 510k Number | K191890 |
| 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 | 2019-07-15 |
| Decision Date | 2020-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712821006592 | K191890 | 000 |
| 05712821012197 | K191890 | 000 |
| 05712821012180 | K191890 | 000 |
| 05712821012173 | K191890 | 000 |
| 05712821012104 | K191890 | 000 |
| 05712821012098 | K191890 | 000 |
| 05712821012081 | K191890 | 000 |
| 05712821012050 | K191890 | 000 |
| 05712821012043 | K191890 | 000 |
| 05712821012029 | K191890 | 000 |
| 05712821012012 | K191890 | 000 |
| 05712821012005 | K191890 | 000 |
| 05712821012203 | K191890 | 000 |
| 05712821012210 | K191890 | 000 |
| 05712821006585 | K191890 | 000 |
| 05712821002518 | K191890 | 000 |
| 05712821002495 | K191890 | 000 |
| 05712821002464 | K191890 | 000 |
| 05712821002440 | K191890 | 000 |
| 05712821002426 | K191890 | 000 |
| 05712821002402 | K191890 | 000 |
| 05712821002099 | K191890 | 000 |
| 05712821001863 | K191890 | 000 |
| 05712821001856 | K191890 | 000 |
| 05712821012234 | K191890 | 000 |
| 05712821013316 | K191890 | 000 |