FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AcceleDent Aura
K Number: K153048
·
Decision Jul 8, 2016
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
4
Applicant Total
3
Review Days
263
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Basic Information
- Device Name
- AcceleDent Aura
- K Number
- K153048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthoaccel Technologies, Inc.
- Date Received
- October 19, 2015
- Decision Date
- July 8, 2016
- Product Code
- OYH
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OYH | Orthodontic Vibratory Accessory | FDA class 2 | Dental |
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