OSSTEM Implant System - Abutment
FDA 510(k) clearance K161689 · decided 2017-05-22
Clearance details
- K-number
- K161689
- Device name
- OSSTEM Implant System - Abutment
- Applicant
- Osstem Implant Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-20
- Decision date
- 2017-05-22
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Busan, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended recall (Z-1274-2025) | Hiossen Inc. | 2025-03-05 |
| Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended recall (Z-1276-2025) | Hiossen Inc. | 2025-03-05 |