| Primary Device ID | 06970402670504 |
| NIH Device Record Key | baddb640-bd5f-428d-bfb6-d578a2921016 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invisible Orthodontic Appliance |
| Version Model Number | LX-A |
| Company DUNS | 528184691 |
| Company Name | SHANDONG HUGE DENTAL MATERIAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 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 | 06970402670504 [Primary] |
| NXC | Aligner, Sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2019-07-12 |
| 06970402670283 - Casting Wax | 2021-11-01 |
| 06970402670290 - Casting Wax | 2021-11-01 |
| 06970402676582 - Synthetic Polymer Teeth | 2021-11-01 |
| 06970402676599 - Synthetic Polymer Teeth | 2021-11-01 |
| 06970402676605 - Synthetic Polymer Teeth | 2021-11-01 |
| 06970402676612 - Synthetic Polymer Teeth | 2021-11-01 |
| 06970402676629 - Synthetic Polymer Teeth | 2021-11-01 |
| 06970402676636 - Synthetic Polymer Teeth | 2021-11-01 |