FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Oral Surgery System and Accessories
K Number: K152125
·
Decision Aug 15, 2016
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
14
Review Days
381
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Basic Information
- Device Name
- Oral Surgery System and Accessories
- K Number
- K152125
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bonart Co., Ltd.
- Date Received
- July 31, 2015
- Decision Date
- August 15, 2016
- Product Code
- DZI
- 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 |
|---|---|---|---|
| DZI | Drill, Bone, Powered | FDA class 2 | Dental |
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