| Primary Device ID | 00850078989161 |
| NIH Device Record Key | c57dc70c-01f3-4f57-8eb8-962517403631 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmileSet Premium Whitening Sample Pen – 3 ml |
| Version Model Number | 150-0123 |
| 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 | false |
| Manufacturing Date | false |
| 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 | |
| Phone | 1-855-604-7052 |
| support@smileset.com | |
| Phone | 1-855-604-7052 |
| support@smileset.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850078989161 [Primary] |
| MAU | Eraser, Dental Stain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-03 |
| Device Publish Date | 2025-09-25 |
| 00850078989109 - SmileSet Sonic Toothbrush Refill Heads - Black with Mint | 2025-10-03 |
| 00850078989116 - SmileSet Sonic Toothbrush Refill Heads - White with Mint | 2025-10-03 |
| 00850078989123 - SmileSet Premium Whitening Kit – Black | 2025-10-03 |
| 00850078989130 - SmileSet Premium Whitening Kit – Mint | 2025-10-03 |
| 00850078989147 - SmileSet Premium Whitening Kit – White | 2025-10-03 |
| 00850078989154 - SmileSet Premium Whitening Refill – 4 Pack | 2025-10-03 |
| 00850078989161 - SmileSet Premium Whitening Sample Pen – 3 ml | 2025-10-03 |
| 00850078989161 - SmileSet Premium Whitening Sample Pen – 3 ml | 2025-10-03 |
| 00850078989178 - SmileSet Premium Sensitive Whitening Strips | 2025-10-03 |