TruFit 2.0

FDA UDI

Class I (US FDA UDI)

by Ortho Technology, Inc.

Identity

Trade Name: TruFit 2.0 FDA UDI
Generic Name: Orthodontic metal band FDA UDI
Device Name: TruFit™ 2.0 ASM .018 ROTH LL7 NC SBT -25T 4DOff CLT 32.5 (3PK) FDA UDI
Model / Reference: 493-91-4720-325-3 FDA UDI
Description: TruFit™ 2.0 ASM .018 ROTH LL7 NC SBT -25T 4DOff CLT 32.5 (3PK) FDA UDI

Identifiers

Primary DI / UDI-DI: 00190730078490 FDA UDI
FDA Product Code: ECM FDA UDI
GMDN Term: Orthodontic metal band 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 metal band

TruFit 2.0 by Ortho Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic metal band.

Elite — Ortho Organizers, Inc. · Class I
dentaform® — Dentaurum · Class I
Epic — Ortho Organizers, Inc. · Class I
Band Assemblies — Ortho Organizers, Inc. · Class I
Tempra — Ortho Organizers, Inc. · Class I
The Orthodontic Store — Young Innovations, Inc. · Class I
CONLIN MOLAR BANDS — ORTHO ARCH COMPANY INC · Class I
Ortho Pro — 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: Ortho Technology, Inc.

Sources (1)

FDA UDI 63242685-0b02-4d52-a7a2-dff8653471fe 33 fields · synced May 30, 2026