| Primary Device ID | 08809917070975 |
| NIH Device Record Key | 54da7777-a08b-47fc-a063-9697a98c7724 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transfer Abutment Separate Tool |
| Version Model Number | TAST |
| Company DUNS | 689051793 |
| Company Name | Osstem Implant Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 08809917070975 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
[08809917070975]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-08 |
| Device Publish Date | 2024-06-30 |
| 08800271260286 - 122 TAPER FULL KIT | 2025-09-15 |
| 08800271260293 - 122 TAPER KIT | 2025-09-15 |
| 08800271260309 - 485 KIT | 2025-09-15 |
| 08800271260316 - TAPER KIT | 2025-09-15 |
| 08809917162229 - OneGuide Taper Drill | 2025-08-01 |
| 08809917162243 - OneGuide Taper Drill | 2025-08-01 |
| 08809917162267 - OneGuide Taper Drill | 2025-08-01 |
| 08809917162274 - OneGuide Taper Drill | 2025-08-01 |