Data / Medical devices / South Korea / Osstem Implant Co., Ltd.
Osstem Implant Co., Ltd.: FDA-registered device maker in SIHEUNG Gyeonggi, South Korea, 6 510(k) clearances
Osstem Implant Co., Ltd. is registered with the FDA (registration 3015332784) in SIHEUNG Gyeonggi, South Korea. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015332784
- Address
- A-Dong, 51, Mayu-Ro 238beon-Gil, SIHEUNG Gyeonggi, South Korea, 15079
- Owner or operator
- OSSTEM IMPLANT CO LTD (9062743)
- Roles
- Manufacturer
- First device listed
- June 15, 2017
- Registered through
- 2026
- Brand names listed
- Estar-Z HT, Estar-Z Multi, Estar-Z ST, Estar-Z T, Estar-ZE, HySil Impression Materials (Heavy, Mono, and Bite), HySil Plus Impression Materials, HySil Super Fast Impression Material and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 20, 2024 | K242521 | Estar-ZE | EIH | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| July 2, 2021 | K210097 | Estar-Z | EIH | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| March 18, 2021 | K210041 | HySil Plus Impression Materials | ELW | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| January 30, 2020 | K192941 | HySil Super Fast Impression Materials | ELW | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| September 13, 2018 | K181236 | HySil Impression Materials | ELW | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| June 7, 2017 | K170736 | HySil Impression Materials | ELW | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression
- All makers of Powder, Porcelain
- All makers of Syringe, Restorative And Impression Material
Updated November 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.