FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GS III SYSTEM
K Number: K091208
·
Decision Mar 3, 2010
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
68
Review Days
313
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GS III SYSTEM
- K Number
- K091208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osstem Implant Co., Ltd.
- Date Received
- April 24, 2009
- Decision Date
- March 3, 2010
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.
MegaGen Zygoma Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
INOSS System
FDA 510(k)
FDA Class 2
·Dental
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
FDA 510(k)
FDA Class 2
·Dental
Adin Long Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
ZENEX Implant System_Short (R-System)
FDA 510(k)
FDA Class 2
·Dental
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 |