FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
K Number: K162856
·
Decision Jul 18, 2017
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
14
Review Days
279
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Basic Information
- Device Name
- Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
- K Number
- K162856
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bonart Co., Ltd.
- Date Received
- October 12, 2016
- Decision Date
- July 18, 2017
- Product Code
- EGS
- 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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