TruFlex

FDA UDI

Class I (US FDA UDI)

by Ortho Technology, Inc.

Identity

Trade Name: TruFlex FDA UDI
Generic Name: Orthodontic spring FDA UDI
Device Name: Closed Coil Springs 9mm Light 10/pk (.010" x .030") FDA UDI
Model / Reference: 700-104L FDA UDI
Description: Closed Coil Springs 9mm Light 10/pk (.010" x .030") FDA UDI

Identifiers

Primary DI / UDI-DI: 00190730022769 FDA UDI
FDA Product Code: ECO FDA UDI
GMDN Term: Orthodontic spring 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 spring

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

Similar devices

Also classified as Orthodontic spring.

Original Side-Winder Uprighting Spring — TP ORTHODONTICS, INC. · Class I
RMO — RMO · Class I
Stainless Steel Closed Coil Spring — ORTHO ARCH COMPANY INC · Class I
Orthodontic Spring — DENTOS Inc. · Class I
OSE — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class I
Begg Spring-Pin — TP ORTHODONTICS, INC. · Class I
Ortho Organizers — Ortho Organizers, Inc. · Class I
3M™ Unitek™ — 3M UNITEK CORPORATION · 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 455dede0-0de0-4e3f-945b-36e7fb539916 33 fields · synced May 30, 2026