IST® Appliance

FDA UDI

Class I (US FDA UDI)

by Scheu-Dental

Identity

Trade Name: IST® Appliance FDA UDI
Generic Name: Orthodontic power arm FDA UDI
Device Name: O-Rings for IST® appliance FDA UDI
Model / Reference: 5466.1 FDA UDI
Description: O-Rings for IST® appliance FDA UDI

Identifiers

Primary DI / UDI-DI: J01854661 FDA UDI
FDA Product Code: DYJ FDA UDI
GMDN Term: Orthodontic power arm FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic power arm

IST® Appliance by Scheu-Dental — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Scheu-Dental

Sources (1)

FDA UDI 15b103ae-0219-4446-950d-b534f7ff8efb 33 fields · synced May 30, 2026