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 | 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 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ELOS ACCURATE 86837307 5135482 Live/Registered |
Elos Medtech AB 2015-12-02 |