The following data is part of a premarket notification filed by Panthera Dental Inc. with the FDA for Panthera Dental Milled Bars.
| Device ID | K183580 |
| 510k Number | K183580 |
| Device Name: | Panthera Dental Milled Bars |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Panthera Dental Inc. 2035 Rue Du Haut-Bord Quebec City, CA G1n 4n7 |
| Contact | Martine Fortin |
| Correspondent | Martine Fortin Panthera Dental Inc. 2035 Rue Du Haut-Bord Quebec City, CA G1n 4n7 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-06-20 |