The following data is part of a premarket notification filed by Orthoaccel Technologies, Inc. with the FDA for Acceledent Aura.
| Device ID | K153048 |
| 510k Number | K153048 |
| Device Name: | AcceleDent Aura |
| Classification | Orthodontic Vibratory Accessory |
| Applicant | ORTHOACCEL TECHNOLOGIES, INC. 6575 WEST LOOP SOUTH, SUITE 200 Bellaire, TX 77401 |
| Contact | Zaffer Syed |
| Correspondent | Zaffer Syed ORTHOACCEL TECHNOLOGIES, INC. 6575 WEST LOOP SOUTH, SUITE 200 Bellaire, TX 77401 |
| Product Code | OYH |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-19 |
| Decision Date | 2016-07-08 |
| Summary: | summary |