OSSTEM Implant System - Abutment— 510(k) K161689
Substantially EquivalentOsstem Implant Co., Ltd.
FDA 510(k) clearance K161689 for OSSTEM Implant System - Abutment, Substantially Equivalent on 2017-05-22. Applicant: Osstem Implant Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Osstem Implant Co., Ltd.
- Product code
- Code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Busan, KR
Recent devices under product code NHA
view allMore clearances from Osstem Implant Co., Ltd.
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K161689
K-number listed on FDA's recall record- Z-1274-2025 — Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
- Z-1276-2025 — Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA505RV1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161689.
Data sourced from openFDA. This site is unofficial and independent of the FDA.