FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
TRAUS SIP20
K Number: K201292
·
Decision Feb 11, 2021
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
18
Review Days
273
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Basic Information
- Device Name
- TRAUS SIP20
- K Number
- K201292
- 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 14, 2020
- Decision Date
- February 11, 2021
- 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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Other Clearances by Saeshin Precision Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10) | Jan 30, 2026 | Substantially Equivalent |
| K233153 | Traus SSG10 Surgical System | Sep 20, 2024 | Substantially Equivalent |
| K232938 | Traus SSG30 Surgical System | Sep 16, 2024 | Substantially Equivalent |
| K221741 | TRAUS Air Dental Handpiece | Feb 22, 2023 | Substantially Equivalent |
| K212043 | TRAUS ENDO | Jun 24, 2022 | Substantially Equivalent |
| K192561 | TRAUS SUS20 | Jul 13, 2020 | Substantially Equivalent |
| K182892 | TRAUS Dental Handpieces | Nov 26, 2019 | Substantially Equivalent |
| K181129 | STRONG Dental Handpieces | Jan 31, 2019 | Substantially Equivalent |
| K171436 | STRONG Dental Handpieces | Jan 5, 2018 | Substantially Equivalent |
| K151171 | TRAUS SUS10 | Sep 1, 2015 | Substantially Equivalent |