Elos Accurate® Customized Abutment
Abutment, Implant, Dental, Endosseous
Elos Medtech Pinol A/S
The following data is part of a premarket notification filed by Elos Medtech Pinol A/s with the FDA for Elos Accurate® Customized Abutment.
Pre-market Notification Details
| Device ID | K190299 |
| 510k Number | K190299 |
| 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 | 2019-02-11 |
| Decision Date | 2019-06-26 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712821003058 | K190299 | 000 |
| 05712821001962 | K190299 | 000 |
| 05712821001979 | K190299 | 000 |
| 05712821002877 | K190299 | 000 |
| 05712821002914 | K190299 | 000 |
| 05712821002938 | K190299 | 000 |
| 05712821002952 | K190299 | 000 |
| 05712821001993 | K190299 | 000 |
| 05712821003034 | K190299 | 000 |
| 05712821001948 | K190299 | 000 |
Trademark Results [Elos Accurate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELOS ACCURATE 86837307 5135482 Live/Registered |
Elos Medtech AB 2015-12-02 |
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