The following data is part of a premarket notification filed by Classone Orthodontics, Inc. with the FDA for Reli-on One Step, Orthodontic Adhesive.
Device ID | K053379 |
510k Number | K053379 |
Device Name: | RELI-ON ONE STEP, ORTHODONTIC ADHESIVE |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | CLASSONE ORTHODONTICS, INC. 5064 50TH ST. Lubbock, TX 79414 |
Contact | Judy Ribordy |
Correspondent | Judy Ribordy CLASSONE ORTHODONTICS, INC. 5064 50TH ST. Lubbock, TX 79414 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-05 |
Decision Date | 2006-01-25 |
Summary: | summary |