FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HS/HG PROSTHETIC SYSTEM
K Number: K100245
·
Decision Aug 17, 2010
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
68
Review Days
202
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Basic Information
- Device Name
- HS/HG PROSTHETIC SYSTEM
- K Number
- K100245
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osstem Implant Co., Ltd.
- Date Received
- January 27, 2010
- Decision Date
- August 17, 2010
- 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 Osstem Implant Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251434 | Healing Abutment System | Mar 4, 2026 | Substantially Equivalent |
| K251569 | Bone Screw | Aug 13, 2025 | Substantially Equivalent |
| K242521 | Estar-ZE | Nov 20, 2024 | Substantially Equivalent |
| K233806 | T2 Plus | Sep 6, 2024 | Substantially Equivalent |
| K233194 | TS Abutment System | Feb 20, 2024 | Substantially Equivalent |
| K232220 | SS Abutment System | Dec 5, 2023 | Substantially Equivalent |
| K232012 | N1 | Nov 28, 2023 | Substantially Equivalent |
| K222778 | Osstem Implant System | Sep 23, 2023 | Substantially Equivalent |
| K221684 | Osstem Abutment System | Sep 8, 2022 | Substantially Equivalent |
| K212303 | T2 | Sep 21, 2021 | Substantially Equivalent |