FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Dentis s-Clean Regular Abutment
K Number: K230126
·
Decision Aug 4, 2023
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
37
Review Days
199
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Basic Information
- Device Name
- Dentis s-Clean Regular Abutment
- K Number
- K230126
- 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
- January 17, 2023
- Decision Date
- August 4, 2023
- 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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Other Clearances by Dentis Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253493 | Dentis SQ-SL AXEL Fixture | Mar 4, 2026 | Substantially Equivalent |
| K241065 | ChecQ (AC100) | Mar 21, 2025 | Substantially Equivalent |
| K233921 | Luvis Chair (LC700C) | Sep 6, 2024 | Substantially Equivalent |
| K241063 | s-Clean ScanHealing Abutment | Jul 25, 2024 | Substantially Equivalent |
| K240511 | Dentis s-Clean SQ-SL Fixture | May 20, 2024 | Substantially Equivalent |
| K233544 | MESHEET | Feb 22, 2024 | Substantially Equivalent |
| K230307 | Dentis i-Clean System | Jul 11, 2023 | Substantially Equivalent |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant System | May 25, 2023 | Substantially Equivalent |
| K230523 | s-Clean Link Abutment Narrow | May 24, 2023 | Substantially Equivalent |
| K230203 | Dentis I-FIX Abutment | May 3, 2023 | Substantially Equivalent |