AcceleDent Aura
FDA 510(k) clearance K153048 · decided 2016-07-08
Clearance details
- K-number
- K153048
- Device name
- AcceleDent Aura
- Applicant
- Orthoaccel Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-10-19
- Decision date
- 2016-07-08
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- OYH
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bellaire, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VPro5 (K183018) | Propel Orthodontics, LLC | 2019-11-01 |
| AcceleDent Optima (K170093) | Orthoaccel Technology, Inc. | 2017-05-26 |
| ACCELEDENT AURA (K130643) | Orthoaccel Technologies, Inc. | 2013-04-23 |
| ACCELEDENT (K110661) | Orthoaccel Technologies, Inc. | 2011-11-17 |
Recalls involving this device
No recalls on record reference this clearance.