FDA 510(k) K080445, LION SE ONE STEP ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc.
FDA 510(k) K080445, LION SE ONE STEP ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc.
| 510(k) Number | K080445 |
| Device Classification Name | Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Name | LION SE ONE STEP ORTHODONTIC ADHESIVE |
| Applicant | Classone Orthodontics, Inc. 5064 50th St. Lubbock, TX 79414 |
| Regulation Number | 872.375 |
| Classification Product Code | DYH |
| Date Received | 02/19/2008 |
| Decision Date | 07/16/2008 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Dental |
| 510k Review Panel | Dental |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 102 |
| Redacted Pages | 28 |
| Unredacted Pages | 74 |
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