510(k) K183475 ยท OAS X-Ray, Tomography, Computed, Dental
T1-CS, T1-C
| Applicant | Osstem Implant Co., Ltd., Siheung-Si, KR |
| Decision | Substantially Equivalent, Aug 30, 2019 |
| Received | Dec 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2025 | OSSTEM Implant Co., Ltd. Osstem Dental X-Ray System T1. Product Model Numbers
T1-C and T1-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.