Arcad Aligners

GUDID 00860011071921

Top and Bottom Aligners

ARCADLAB

Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit Orthodontic aligner auxiliary attachment kit

Primary Device ID	00860011071921
NIH Device Record Key	67d424b8-18c2-4950-a826-6542efdf77de
Commercial Distribution Status	In Commercial Distribution
Brand Name	Arcad Aligners
Version Model Number	Clear Orthodontic Aligners
Company DUNS	080230996
Company Name	ARCADLAB
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	true
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011071921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192244

FDA Product Code

PNN	Orthodontic software

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-11-27
Device Publish Date	2023-11-17