SmileSet All-Day Aligners

GUDID 00860012825509

Orthodontic progressive aligner

Primary Device ID	00860012825509
NIH Device Record Key	15beb0bd-8e29-40d7-a1ba-f7487b006ba0
Commercial Distribution Status	In Commercial Distribution
Brand Name	SmileSet All-Day Aligners
Version Model Number	121-0106
Company DUNS	119338749
Company Name	Ortho Dental Lab LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860012825509 [Primary]

NXC	Aligner, Sequential

Steralize Prior To Use	false
Device Is Sterile	false

00850078989086 - SmileSet Sonic Toothbrush – Black with Mint Accents	2025-09-12
00850078989093 - SmileSet Sonic Toothbrush – White with Mint Accents	2025-09-12
00860014476136 - SmileSet Night Guard	2025-09-12
00860012825592 - SmileSet Retainers	2025-09-11
00860014476105 - SmileSet Nighttime Aligners	2025-09-11
00860012825509 - SmileSet All-Day Aligners	2025-09-05
00860012825509 - SmileSet All-Day Aligners	2025-09-05