510(k) K212303 ยท OAS X-Ray, Tomography, Computed, Dental
T2
| Applicant | Osstem Implant Co., Ltd., Siheung-Si, KR |
| Decision | Substantially Equivalent, Sep 21, 2021 |
| Received | Jul 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212303
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2025 | OSSTEM Implant Co., Ltd. Osstem Dental X-Ray System T2. Product Model Numbers
T2-C and T2-CS. Open, Classified |
OAS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.