| Primary Device ID | 08806383551014 |
| NIH Device Record Key | 2057e9ae-b463-4174-a410-ed82faba5fb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endo Shaping Blocks |
| Version Model Number | 943-101 |
| Catalog Number | 943-101 |
| Company DUNS | 687789453 |
| Company Name | DiaDent Group International |
| 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 | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 ** Keep Dry and Keep away from Sunlight. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806383551014 [Primary] |
| EIL | Gauge, Depth, Instrument, 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 | 2023-07-05 |
| Device Publish Date | 2023-06-27 |
| 08806383586313 - DUO-GUN | 2025-03-20 Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable vertical injection of softened Gut |
| 08806383586320 - DUO-PEN | 2025-03-20 Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Perch |
| 08806383534758 - GUTTA PERCHA OBTURATOR | 2023-07-05 GUTTA PERCHA OBTURATOR is used to root canal filing material. |
| 08806383551014 - Endo Shaping Blocks | 2023-07-05Clear acrylic blocks with high transparency for new technique training. |
| 08806383551014 - Endo Shaping Blocks | 2023-07-05 Clear acrylic blocks with high transparency for new technique training. |
| 08806383565608 - DISPOSABLE TIPS | 2023-07-05 Disposable Tip for DiaFil Flow |
| 08806383565615 - DISPOSABLE TIPS | 2023-07-05 Disposable Tips for DiaEtch |
| 08806383565660 - DISPOSABLE TIPS | 2023-07-05 Disposable Tips for DiaFil Flow |
| 08806383565677 - DISPOSABLE TIPS | 2023-07-05 Disposable Tips for DiaEtch |