SmileSet Sonic Toothbrush – Black with Mint Accents

GUDID 00850078989086

Ortho Dental Lab LLC

Basic electric toothbrush
Primary Device ID00850078989086
NIH Device Record Key13c63008-b8b2-44a0-9431-5d6702c12d68
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmileSet Sonic Toothbrush – Black with Mint Accents
Version Model Number150-0107
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850078989086 [Primary]

FDA Product Code

JEQToothbrush, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-12
Device Publish Date2025-09-04

Devices Manufactured by Ortho Dental Lab LLC

00850078989086 - SmileSet Sonic Toothbrush – Black with Mint Accents2025-09-12
00850078989086 - SmileSet Sonic Toothbrush – Black with Mint Accents2025-09-12
00850078989093 - SmileSet Sonic Toothbrush – White with Mint Accents2025-09-12
00860014476136 - SmileSet Night Guard2025-09-12
00860012825592 - SmileSet Retainers2025-09-11
00860014476105 - SmileSet Nighttime Aligners2025-09-11
00860012825509 - SmileSet All-Day Aligners2025-09-05

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