The following data is part of a premarket notification filed by Panthera Dental Inc. with the FDA for Panthera Dental Milled Bars.
Device ID | K173466 |
510k Number | K173466 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-08 |
Decision Date | 2018-01-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07540204000039 | K173466 | 000 |