| Primary Device ID | 08809986620491 |
| NIH Device Record Key | 205b53a6-e193-4ad3-b347-6233011c77d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trephine Bur |
| Version Model Number | TB4535S |
| Company DUNS | 631169224 |
| Company Name | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | 08809986620491 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809986620491]
Moist Heat or Steam Sterilization
[08809986620491]
Moist Heat or Steam Sterilization
[08809986620491]
Moist Heat or Steam Sterilization
[08809986620491]
Moist Heat or Steam Sterilization
[08809986620491]
Moist Heat or Steam Sterilization
[08809986620491]
Moist Heat or Steam Sterilization
[08809986620491]
Moist Heat or Steam Sterilization
[08809986620491]
Moist Heat or Steam Sterilization
[08809986620491]
Moist Heat or Steam Sterilization
[08809986620491]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-16 |
| Device Publish Date | 2026-03-06 |
| 08809986620514 | TB4030S |
| 08809986620507 | TB4030L |
| 08809986620491 | TB4535S |
| 08809986620484 | TB4535L |
| 08809986620477 | TB5040S |
| 08809986620460 | TB5040L |
| 08809986620453 | TB5545S |
| 08809986620446 | TB5545L |
| 08809986620439 | TB6050S |
| 08809986620422 | TB6050L |