Arcad Aligners

FDA UDI

Class II (US FDA UDI)

by Arcadlab

Identity

Trade Name: Arcad Aligners FDA UDI
Generic Name: Orthodontic aligner auxiliary attachment kit FDA UDI
Device Name: Top and Bottom Aligners FDA UDI
Model / Reference: Clear Orthodontic Aligners FDA UDI
Description: Top and Bottom Aligners FDA UDI

Identifiers

Primary DI / UDI-DI: 00860011071921 FDA UDI
510(k) Number: K192244 FDA UDI
FDA Product Code: PNN FDA UDI
NXC FDA UDI
GMDN Term: Orthodontic aligner auxiliary attachment kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Orthodontic aligner auxiliary attachment kit

Arcad Aligners by Arcadlab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Arcadlab

Sources (1)

FDA UDI 67d424b8-18c2-4950-a826-6542efdf77de 34 fields · synced May 30, 2026