The following data is part of a premarket notification filed by Panthera Dental Inc. with the FDA for Panthera Dental Milled Bars.
| Device ID | K192108 |
| 510k Number | K192108 |
| 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. 9105 Rue John-Simons Quebec City, CA G2b 0s6 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2020-04-08 |