FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Eco Abutment, Multiunit Abutment
K Number: K220253
·
Decision Aug 18, 2023
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
14
Review Days
564
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Basic Information
- Device Name
- Eco Abutment, Multiunit Abutment
- K Number
- K220253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dio Corporation
- Date Received
- January 31, 2022
- Decision Date
- August 18, 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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|---|---|---|---|
| K210828 | DIOnavi-Denture02 | Mar 23, 2021 | Substantially Equivalent |
| K193623 | DIOnavi-Denture | Oct 22, 2020 | Substantially Equivalent |
| K193404 | UF(II) Bar holder abutment | May 18, 2020 | Substantially Equivalent |
| K192263 | UCLA CCM Abutment | Feb 21, 2020 | Substantially Equivalent |
| K190048 | UF(II) Anatomic abutment | Sep 30, 2019 | Substantially Equivalent |
| K181037 | DIO CAD/CAM Abutment | Dec 21, 2018 | Substantially Equivalent |
| K182194 | UV Active Implant System | Dec 14, 2018 | Substantially Equivalent |
| K173975 | UF(II) Wide Fixture | Jun 1, 2018 | Substantially Equivalent |
| K170608 | UF(II) Implant System | Mar 30, 2018 | Substantially Equivalent |
| K161987 | UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure | Feb 21, 2017 | Substantially Equivalent |