FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
iCTmotor (WL-1)
K Number: K193341
·
Decision Sep 4, 2020
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
22
Review Days
276
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Basic Information
- Device Name
- iCTmotor (WL-1)
- K Number
- K193341
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentium Co., Ltd.
- Date Received
- December 3, 2019
- Decision Date
- September 4, 2020
- 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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