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 |