The following data is part of a premarket notification filed by Orthoaccel Technologies, Inc with the FDA for Acceledent Aura.
| Device ID | K130643 |
| 510k Number | K130643 |
| Device Name: | ACCELEDENT AURA |
| Classification | Orthodontic Vibratory Accessory |
| Applicant | ORTHOACCEL TECHNOLOGIES, INC 6575 WEST LOOP SOUTH, STE 200 Bellaire, TX 77401 |
| Contact | Zaffer Syed |
| Correspondent | Zaffer Syed ORTHOACCEL TECHNOLOGIES, INC 6575 WEST LOOP SOUTH, STE 200 Bellaire, TX 77401 |
| Product Code | OYH |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865515000200 | K130643 | 000 |