FDA 510(k) K053379, RELI-ON ONE STEP, ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc.
FDA 510(k) K053379, RELI-ON ONE STEP, ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc.
| 510(k) Number | K053379 |
| Device Classification Name | Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Name | RELI-ON ONE STEP, ORTHODONTIC ADHESIVE |
| Applicant | Classone Orthodontics, Inc. 5064 50th St. Lubbock, TX 79414 |
| Regulation Number | 872.375 |
| Classification Product Code | DYH |
| Date Received | 12/05/2005 |
| Decision Date | 01/25/2006 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Dental |
| 510k Review Panel | Dental |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 54 |
| Redacted Pages | 2 |
| Unredacted Pages | 52 |
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