FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
s-Clean Pre-Milled Abutment
K Number: K210362
·
Decision Aug 19, 2021
Classifications
1
FEI Numbers
390
Registration Numbers
390
Same Product Code
672
Applicant Total
22
Review Days
192
Basic Information
- Device Name
- s-Clean Pre-Milled Abutment
- K Number
- K210362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentis Co., Ltd.
- Date Received
- February 8, 2021
- Decision Date
- August 19, 2021
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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|---|---|---|---|
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