FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EK MULTI ANGLED 30 ABUTMENT
K Number: K251427
·
Decision Jan 29, 2026
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
26
Review Days
266
Basic Information
- Device Name
- EK MULTI ANGLED 30 ABUTMENT
- K Number
- K251427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hiossen, Inc.
- Date Received
- May 8, 2025
- Decision Date
- January 29, 2026
- 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 Hiossen, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | May 14, 2026 | Substantially Equivalent |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | Jan 8, 2025 | Substantially Equivalent |
| K240232 | EK D3.3 and Ultra Wide Implants | Sep 13, 2024 | Substantially Equivalent |
| K233389 | EK Digital Abutments | May 29, 2024 | Substantially Equivalent |
| K222636 | ET Abutment System | Apr 28, 2023 | Substantially Equivalent |
| K203360 | EK Implants and Abutments System | Jan 7, 2022 | Substantially Equivalent |
| K191751 | EM Provisional | Dec 16, 2019 | Substantially Equivalent |
| K191201 | EM SA Implant System | Nov 15, 2019 | Substantially Equivalent |
| K183242 | ET IV SA Dental Implants | May 21, 2019 | Substantially Equivalent |
| K180527 | IS3 | May 16, 2018 | Substantially Equivalent |