FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
Motor Handpiece and Control Unit (SDI10)
K Number: K251407
·
Decision Jan 30, 2026
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
18
Review Days
269
Basic Information
- Device Name
- Motor Handpiece and Control Unit (SDI10)
- K Number
- K251407
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Saeshin Precision Co., Ltd.
- Date Received
- May 6, 2025
- Decision Date
- January 30, 2026
- 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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| K181129 | STRONG Dental Handpieces | Jan 31, 2019 | Substantially Equivalent |
| K171436 | STRONG Dental Handpieces | Jan 5, 2018 | Substantially Equivalent |
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