FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IS3
K Number: K180527
·
Decision May 16, 2018
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
26
Review Days
77
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Basic Information
- Device Name
- IS3
- K Number
- K180527
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hiossen, Inc.
- Date Received
- February 28, 2018
- Decision Date
- May 16, 2018
- 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 Hiossen, Inc.
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|---|---|---|---|
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| K251427 | EK MULTI ANGLED 30 ABUTMENT | Jan 29, 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 |