Cemented Plus Abutment— 510(k) K262207
Substantially EquivalentUnidental Co., Ltd.
FDA 510(k) clearance K262207 for Cemented Plus Abutment, Substantially Equivalent on 2026-09-23. Applicant: Unidental Co., Ltd.. Device class: 2.
Summary
The Cemented Plus Abutment from Unidental Co., Ltd. is filed under NHA, endosseous dental implant abutments. The name indicates an abutment for cement-retained restorations. The record doesn't say which implant systems it fits.
Class II, 21 CFR 872.3630. The Dental panel reviewed it as a Traditional 510(k).
Unidental filed from Gwangmyeong-Si, South Korea. Review took 85 days (June 30 to September 23, 2026).
Clearance details
- Applicant
- Unidental Co., Ltd.
- Product code
- Product code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gwangmyeong-Si, KR
Recent devices under product code NHA
view allMore clearances from Unidental Co., Ltd.
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.