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 |