| Primary Device ID | 08800000995793 |
| NIH Device Record Key | 1ca90504-25ec-4c91-8b96-3e23fb793768 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T1-C |
| Version Model Number | T1-C |
| Company DUNS | 694893867 |
| Company Name | Osstem Implant Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800000995793 [Primary] |
| OAS | X-Ray, Tomography, Computed, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-06 |
| Device Publish Date | 2021-04-28 |
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| 08800000996059 - T2 Plus | 2025-05-06 T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray |
| 08800000995977 - OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS | 2025-05-02 The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by |
| 08800000995984 - OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS | 2025-05-02 The K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use b |
| 08800209338841 - Estar-ZE | 2024-12-11 |
| 08800209338865 - Estar-ZE | 2024-12-11 |
| 08800209338889 - Estar-ZE | 2024-12-11 |
| 08800209338902 - Estar-ZE | 2024-12-11 |