The following data is part of a premarket notification filed by Propel Orthodontics Llc with the FDA for Vpro5.
Device ID | K183018 |
510k Number | K183018 |
Device Name: | VPro5 |
Classification | Orthodontic Vibratory Accessory |
Applicant | Propel Orthodontics LLC 394 South Abbott Ave Milpitas, CA 95035 |
Contact | Bryce Way |
Correspondent | Bryce Way Propel Orthodontics LLC 394 South Abbott Ave Milpitas, CA 95035 |
Product Code | OYH |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-31 |
Decision Date | 2019-11-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VPRO5 86951586 5111329 Live/Registered |
ADVANCED ORTHODONTICS AND EDUCATION ASSOCIATION, LLC 2016-03-24 |