SmileSet Retainers

GUDID 00860012825592

Ortho Dental Lab LLC

Orthodontic retainer
Primary Device ID00860012825592
NIH Device Record Key602bc279-4872-4f5c-ae7a-6a94221ffcee
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmileSet Retainers
Version Model Number140-0101
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 Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100860012825592 [Primary]

FDA Product Code

KMYPositioner, Tooth, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-11
Device Publish Date2025-09-03

Devices Manufactured by Ortho Dental Lab LLC

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
00860012825592 - SmileSet Retainers2025-09-11
00860014476105 - SmileSet Nighttime Aligners2025-09-11
00860012825509 - SmileSet All-Day Aligners2025-09-05

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