SmileSet WF500 Water Flosser – White

GUDID 00850078989000

Ortho Dental Lab LLC

Water jet flosser
Primary Device ID00850078989000
NIH Device Record Key076e58c7-0c63-4a79-ad65-f94919eabcd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmileSet WF500 Water Flosser – White
Version Model Number150-0109
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
GS100850078989000 [Primary]

FDA Product Code

EFSUnit, Oral Irrigation

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
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
00850078989062 - Smileset Rechargeable Ultrasonic Cleaner – Mint2025-09-25
00850078989079 - Smileset Rechargeable Ultrasonic Cleaner – White2025-09-25

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