| Primary Device ID | 00860014476105 |
| NIH Device Record Key | 822fc708-0b36-410b-b25c-8d2061b5eae8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmileSet Nighttime Aligners |
| Version Model Number | 122-0101 |
| Company DUNS | 119338749 |
| Company Name | Ortho Dental Lab 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 | 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 |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860014476105 [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 | 2025-09-11 |
| Device Publish Date | 2025-09-03 |