| Primary Device ID | 00850078989024 |
| NIH Device Record Key | e5bc6a2f-de1a-4ac7-9d3c-91794e266371 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmileSet Water Flosser Replacement Tips - 4 pack |
| Version Model Number | 150-0111 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850078989024 [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 | 2025-09-25 |
| Device Publish Date | 2025-09-17 |
| 00850078989000 - SmileSet WF500 Water Flosser – White | 2025-09-25 |
| 00850078989017 - SmileSet QX105 Ultrasonic Cleaner - Black | 2025-09-25 |
| 00850078989024 - SmileSet Water Flosser Replacement Tips - 4 pack | 2025-09-25 |
| 00850078989024 - SmileSet Water Flosser Replacement Tips - 4 pack | 2025-09-25 |
| 00850078989031 - SmileSet QX105 Ultrasonic Cleaner - Mint | 2025-09-25 |
| 00850078989048 - SmileSet QX105 Ultrasonic Cleaner - White | 2025-09-25 |
| 00850078989055 - SmileSet Rechargeable Ultrasonic Cleaner - Black | 2025-09-25 |
| 00850078989062 - Smileset Rechargeable Ultrasonic Cleaner – Mint | 2025-09-25 |
| 00850078989079 - Smileset Rechargeable Ultrasonic Cleaner – White | 2025-09-25 |