The following data is part of a premarket notification filed by American Orthodontics with the FDA for Nickle-titanium Orthodontic Wire.
Device ID | K891327 |
510k Number | K891327 |
Device Name: | NICKLE-TITANIUM ORTHODONTIC WIRE |
Classification | Detector, Air Bubble |
Applicant | AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
Contact | Paul Riddle |
Correspondent | Paul Riddle AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
Product Code | FJF |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-10 |
Decision Date | 1989-05-10 |