| Primary Device ID | 00860012825592 |
| NIH Device Record Key | 602bc279-4872-4f5c-ae7a-6a94221ffcee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmileSet Retainers |
| Version Model Number | 140-0101 |
| Company DUNS | 119338749 |
| Company Name | Ortho Dental Lab LLC |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 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 | 00860012825592 [Primary] |
| KMY | Positioner, Tooth, Preformed |
| 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 |