Facility
OSSTEM IMPLANT CO., LTD.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3003394081 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, KR 48002 |
| Registration status | Active · expires 2026 |
| Parent company | OSSTEM IMPLANT CO LTD (owner-operator 9062743) |
| Brand names | Orthodontic Screw |
Devices registered here (1)
- Implant, Endosseous, OrthodonticProduct code OAT · Class II · Dental · 21 CFR 872.3640
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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