| Primary Device ID | 08800070237052 |
| NIH Device Record Key | c9273941-23f5-47f5-8439-8641ee431bdf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Twist Drill (Non-stopper) |
| Version Model Number | TDN3F25L |
| Company DUNS | 694625347 |
| Company Name | Izenimplant 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 | false |
| 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 | 08800070237052 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
[08800070237052]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-07 |
| Device Publish Date | 2025-06-27 |
| 08800070235096 | TDN3F46S |
| 08800070235089 | TDN3F36S |
| 08800070235072 | TDN3F27S |
| 08800070235034 | TDN3F46L |
| 08800070235027 | TDN3F36L |
| 08800070235010 | TDN3F27L |
| 08800070234976 | TDN3F41S |
| 08800070234969 | TDN3F30S |
| 08800070234952 | TDN2F22S |
| 08800070234907 | TDN3F41L |
| 08800070234891 | TDN3F30L |
| 08800070234884 | TDN2F22L |
| 08800070237069 | TDN3F25S |
| 08800070237052 | TDN3F25L |