The following data is part of a premarket notification filed by Orthoaccel Technologies, Inc with the FDA for Acceledent.
| Device ID | K110661 | 
| 510k Number | K110661 | 
| Device Name: | ACCELEDENT | 
| Classification | Orthodontic Vibratory Accessory | 
| Applicant | ORTHOACCEL TECHNOLOGIES, INC 8275 EL RIO, SUITE 100 Houston, TX 77054 | 
| Contact | Michael E Kaufman | 
| Correspondent | Michael E Kaufman ORTHOACCEL TECHNOLOGIES, INC 8275 EL RIO, SUITE 100 Houston, TX 77054 | 
| Product Code | OYH | 
| CFR Regulation Number | 872.5470 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2011-03-08 | 
| Decision Date | 2011-11-17 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ACCELEDENT  85175399  4181657 Live/Registered | OrthoAccel Technologies, Inc 2010-11-12 |