SmileSet Premium Whitening Kit – Black

GUDID 00850078989123

Ortho Dental Lab LLC

Teeth whitening kit
Primary Device ID00850078989123
NIH Device Record Key104125f0-56be-4e6a-a400-9f805eaebeda
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmileSet Premium Whitening Kit – Black
Version Model Number150-0119
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 Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850078989123 [Primary]

FDA Product Code

MAUEraser, Dental Stain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-03
Device Publish Date2025-09-25

Devices Manufactured by Ortho Dental Lab LLC

00850078989109 - SmileSet Sonic Toothbrush Refill Heads - Black with Mint2025-10-03
00850078989116 - SmileSet Sonic Toothbrush Refill Heads - White with Mint2025-10-03
00850078989123 - SmileSet Premium Whitening Kit – Black2025-10-03
00850078989123 - SmileSet Premium Whitening Kit – Black2025-10-03
00850078989130 - SmileSet Premium Whitening Kit – Mint2025-10-03
00850078989147 - SmileSet Premium Whitening Kit – White2025-10-03
00850078989154 - SmileSet Premium Whitening Refill – 4 Pack2025-10-03
00850078989161 - SmileSet Premium Whitening Sample Pen – 3 ml2025-10-03
00850078989178 - SmileSet Premium Sensitive Whitening Strips2025-10-03

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