| Primary Device ID | D819700500 |
| NIH Device Record Key | 34030a3f-147e-4890-aadf-257a10f935f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear Image Aligner |
| Version Model Number | 700015 |
| Company DUNS | 106645484 |
| Company Name | SPECIALTY APPLIANCES, LLC |
| 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 | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8197000150 [Primary] |
| HIBCC | D819700500 [Primary] |
| NXC | Aligner, Sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-12 |
| Device Publish Date | 2017-12-12 |
| D819702400 | Aligner G 2- Dual Arch |
| D819702300 | Aligner G 2- Single Arch |
| D819702200 | Aligner G 1- Dual Arch |
| D819702100 | 70210 |
| D819700610 | Series 5 - Dual Arch Aligner |
| D819700600 | Series 4 - Dual Arch Aligner |
| D819700510 | Series 5 - Single Arch Aligner |
| D819700500 | Series 4 - Single Arch Aligner |
| D819700420 | Series 3 - Dual Arch Aligner |
| D819700410 | 70041 |
| D819700400 | Dual Arch Aligner |
| D819700320 | Series 2 - Dual Arch Aligner |
| D819700310 | Series 2 - Single Arch Aligner |
| D819700300 | 70030 |
| D8197000250 | Aligner G 1- Single Arch |
| D8197000100 | Series 3 - Single Arch Aligner |
| D8197000000 | Single Arch Aligner |
| D8197000700 | 700070 |
| D8197000690 | CIA Plus: Lower |
| D8197000680 | CIA Select: Lower |
| D8197000670 | CIA Plus: Upper |
| D8197000660 | Clear Image Aligner Select: Upper |
| D8197000320 | Series 10 - Dual Arch |
| D8197000310 | Series 10 - Single Arch |