Facility
OSSTEM IMPLANT CO.,LTD.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3045816948 |
|---|---|
| Establishment type | Foreign Private Label Distributor; Export Device to the United States But Perform No Other Operation on Device |
| Location | 104 Cheomdan-daero Yeonsu-gu Incheon, KR 21989 |
| Registration status | Active · expires 2026 |
| Parent company | Osstem Implant Co.,Ltd. (owner-operator 10095871) |
| Brand names | S2 (digital intra-oral X-ray sensor) |
Devices registered here (1)
- Unit, X-Ray, IntraoralProduct code EAP · Class II · Dental · 21 CFR 872.1810
Recalls & enforcement
- Class IIOngoing2025-08-26Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following stat
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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