FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
ChecQ (AC100)
K Number: K241065
·
Decision Mar 21, 2025
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
37
Review Days
337
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Basic Information
- Device Name
- ChecQ (AC100)
- K Number
- K241065
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentis Co., Ltd.
- Date Received
- April 18, 2024
- Decision Date
- March 21, 2025
- Product Code
- EKX
- 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 |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | FDA class 1 | 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 |
| 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 |
| K230126 | Dentis s-Clean Regular Abutment | Aug 4, 2023 | 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 |