Trueform

FDA UDI

Class I (US FDA UDI)

by G&H Wire Company, Inc.

Identity

Trade Name: TRUEFORM FDA UDI
Generic Name: Orthodontic archwire FDA UDI
Device Name: SE NITI TFII LOWER 016x016 FDA UDI
Model / Reference: SETFL3616X FDA UDI
Description: SE NITI TFII LOWER 016x016 FDA UDI

Identifiers

Primary DI / UDI-DI: 10190886092170 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

Dimensions & Sizes

Size: Width — .016 Inch FDA UDI
Height — .016 Inch FDA UDI

Category: Orthodontic archwire

Trueform by G&H Wire Company, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic archwire.

NITANIUM® RCS STRAIGHT LEGS — Ortho Organizers, Inc. · Class I
3M™ Unitek™ — 3M UNITEK CORPORATION · Class I
Masel — Ortho Organizers, Inc. · Class I
Stainless Steel Archwires — Ortho Organizers, Inc. · Class I
remanium® — Dentaurum · Class I
Wires & Accessories — World Class Technology Corporation · Class I
RMO — RMO · Class I
ALPHA-WIRES — Ortho Pro Dent LLC · Class I

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: G&H Wire Company, Inc.

Sources (1)

FDA UDI a3e824e9-9d83-4e9e-8fab-4315cdd338b1 35 fields · synced Jun 8, 2026