AcceleDent Aura
by Orthoaccel Technologies, Inc. GUDID
Withdrawn
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00865515000200 | Date6 Sep 2016 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- AcceleDent
- Generic Name
- Orthodontic vibrator
- Model / Reference
- Aura
- Primary DI / UDI-DI
- 00865515000200
- FDA Product Code
- OYH
- GMDN Term
- Orthodontic vibrator
- Device Class
- Class II
- Regulation Number
- 872.5470
- Commercial Distribution
- Not in Commercial Distribution
Other devices from Orthoaccel Technologies, Inc.
Properties
Other properties (9)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No