510(k) K153048
K153048 is an FDA 510(k) premarket notification submitted by Orthoaccel Technologies, Inc. for the device "AcceleDent Aura". The FDA issued a decision of Substantially Equivalent on July 8, 2016. The device falls under product code OYH (Orthodontic Vibratory Accessory), a Class II device regulated under 21 CFR 872.5470. Orthoaccel Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2016
- Date Received
- October 19, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthodontic Vibratory Accessory
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.