Primary Device ID | 00850078989048 |
NIH Device Record Key | 806e9f4e-42c8-4a12-96c8-280466007820 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SmileSet QX105 Ultrasonic Cleaner - White |
Version Model Number | 150-0113 |
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 | |
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 | 00850078989048 [Primary] |
FLG | Cleaner, Ultrasonic, Medical Instrument |
NOB | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile |
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 |
00850078989031 - SmileSet QX105 Ultrasonic Cleaner - Mint | 2025-09-25 |
00850078989048 - SmileSet QX105 Ultrasonic Cleaner - White | 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 |