Insignia

FDA UDI

Class I (US FDA UDI)

by Ormco Corporation

Identity

Trade Name: Insignia FDA UDI
Generic Name: Orthodontic archwire FDA UDI
Device Name: INSIGNIA LWR ARCHWIRE-TMA 21 X 25 FDA UDI
Model / Reference: 728-1307 FDA UDI
Description: INSIGNIA LWR ARCHWIRE-TMA 21 X 25 FDA UDI

Identifiers

Primary DI / UDI-DI: 00889989061178 FDA UDI
FDA Product Code: DZC FDA UDI
GMDN Term: Orthodontic archwire 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

Yes

FDA UDI

Category: Orthodontic archwire

Insignia by Ormco Corporation — 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: Ormco Corporation

Sources (1)

FDA UDI 8c073c19-d290-45b5-8088-3e67a85a3a83 35 fields · synced Jun 9, 2026