AcceleDent Optima
FDA 510(k) clearance K170093 · decided 2017-05-26
Clearance details
- K-number
- K170093
- Device name
- AcceleDent Optima
- Applicant
- Orthoaccel Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-11
- Decision date
- 2017-05-26
- Days to decision
- 135 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
+ Add to Predicate Builder ◉ Watch Orthoaccel Technology
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 Aura (K153048) | Orthoaccel Technologies, Inc. | 2016-07-08 |
| 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.