SmileSet Rechargeable Ultrasonic Cleaner - Black

GUDID 00850078989055

Ortho Dental Lab LLC

Orthodontic appliance automated cleaner
Primary Device ID00850078989055
NIH Device Record Key48955f21-116f-4da3-a983-99b33c2d01fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmileSet Rechargeable Ultrasonic Cleaner - Black
Version Model Number150-0114
Company DUNS119338749
Company NameOrtho Dental Lab LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com
Phone1-855-604-7052
Emailsupport@smileset.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850078989055 [Primary]

FDA Product Code

FLGCleaner, Ultrasonic, Medical Instrument
NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-25
Device Publish Date2025-09-17

Devices Manufactured by Ortho Dental Lab LLC

00850078989000 - SmileSet WF500 Water Flosser – White2025-09-25
00850078989017 - SmileSet QX105 Ultrasonic Cleaner - Black2025-09-25
00850078989024 - SmileSet Water Flosser Replacement Tips - 4 pack2025-09-25
00850078989031 - SmileSet QX105 Ultrasonic Cleaner - Mint2025-09-25
00850078989048 - SmileSet QX105 Ultrasonic Cleaner - White2025-09-25
00850078989055 - SmileSet Rechargeable Ultrasonic Cleaner - Black2025-09-25
00850078989055 - SmileSet Rechargeable Ultrasonic Cleaner - Black2025-09-25
00850078989062 - Smileset Rechargeable Ultrasonic Cleaner – Mint2025-09-25
00850078989079 - Smileset Rechargeable Ultrasonic Cleaner – White2025-09-25

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