| Primary Device ID | 00860014476129 |
| NIH Device Record Key | a3ed6b66-dbde-44d2-9d5d-8ab5a59ad7f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmileSet Premium Handheld Water Flosser – Mint |
| Version Model Number | 150-0140 |
| 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 | false |
| 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 | 00860014476129 [Primary] |
| EFS | Unit, Oral Irrigation |
| 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 |