The following data is part of a premarket notification filed by Classone Orthodontics, Inc. with the FDA for Lion Se One Step Orthodontic Adhesive.
| Device ID | K080445 |
| 510k Number | K080445 |
| Device Name: | LION SE 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 | 2008-02-19 |
| Decision Date | 2008-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858290006550 | K080445 | 000 |
| 00858290006543 | K080445 | 000 |
| D82813302270 | K080445 | 000 |