FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTBUILDER SYSTEM
K Number: K120951
·
Decision Oct 3, 2012
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
68
Review Days
187
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Basic Information
- Device Name
- SMARTBUILDER SYSTEM
- K Number
- K120951
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osstem Implant Co., Ltd.
- Date Received
- March 30, 2012
- Decision Date
- October 3, 2012
- Product Code
- JEY
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Osstem Implant Co., Ltd.
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|---|---|---|---|
| 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 |