| Primary Device ID | 08800076473263 |
| NIH Device Record Key | 660e84c8-bef8-426f-a64d-d100cdef162f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tru ASC Pro Kit |
| Version Model Number | TAPK01 |
| Company DUNS | 694514760 |
| Company Name | Truabutment Korea Co.,Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800076473263 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800076473263]
Moist Heat or Steam Sterilization
[08800076473263]
Moist Heat or Steam Sterilization
[08800076473263]
Moist Heat or Steam Sterilization
[08800076473263]
Moist Heat or Steam Sterilization
[08800076473263]
Moist Heat or Steam Sterilization
[08800076473263]
Moist Heat or Steam Sterilization
[08800076473263]
Moist Heat or Steam Sterilization
[08800076473263]
Moist Heat or Steam Sterilization
[08800076473263]
Moist Heat or Steam Sterilization
[08800076473263]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-11 |
| Device Publish Date | 2025-12-03 |
| 08800076460928 - AOT Plus Impression Screw | 2025-12-11 |
| 08800076460935 - AOT Plus Impression Screw | 2025-12-11 |
| 08800076460942 - AOT Plus Impression Screw | 2025-12-11 |
| 08800076460959 - AOT Plus Impression Screw | 2025-12-11 |
| 08800076460966 - AOT Plus Impression Screw | 2025-12-11 |
| 08800076460973 - AOT Plus Impression Screw | 2025-12-11 |
| 08800076460980 - AOT Plus Impression Screw | 2025-12-11 |
| 08800076460997 - AOT Plus Impression Screw | 2025-12-11 |