FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
XSmart iQ
K Number: K161213
·
Decision Feb 10, 2017
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
65
Review Days
287
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Basic Information
- Device Name
- XSmart iQ
- K Number
- K161213
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply Sirona
- Date Received
- April 29, 2016
- Decision Date
- February 10, 2017
- Product Code
- EBW
- 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 |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | FDA class 1 | Dental |
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