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: TH NITI TFI UP 016x025 DIMPLED FDA UDI
Model / Reference: TTFU1625DX FDA UDI
Description: TH NITI TFI UP 016x025 DIMPLED FDA UDI

Identifiers

Primary DI / UDI-DI: 10190886099599 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: Height — .016 Inch FDA UDI
Width — .025 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

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Also classified as Orthodontic archwire.

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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 5cfa7920-917a-4d18-b692-af94b4b36d98 35 fields · synced Jun 8, 2026