equilibrium®

FDA UDI

Class I (US FDA UDI)

by Dentaurum

Identity

Trade Name: equilibrium® FDA UDI
Generic Name: Orthodontic bracket, metal FDA UDI
Device Name: equilibrium® 2 Bracket, 0° Torque, 0° Angulation for tooth 24 FDA UDI
Model / Reference: 722-305-24 FDA UDI
Description: equilibrium® 2 Bracket, 0° Torque, 0° Angulation for tooth 24 FDA UDI

Identifiers

Primary DI / UDI-DI: J011722305240 FDA UDI
FDA Product Code: EJF FDA UDI
GMDN Term: Orthodontic bracket, metal 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

FDA UDI

Category: Orthodontic bracket, metal

equilibrium® by Dentaurum — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket, metal.

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Intrigue — LANCER ORTHODONTICS, INC. · Class II
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LEGEND — GC Orthodontics America Inc. · Class I
MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
RMO — RMO · Class I
Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
Votion — ORTHO TECHNOLOGY, INC. · 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: Dentaurum

Sources (1)

FDA UDI f379c67e-49d9-4616-b450-3b6a0bfcbfb7 35 fields · synced May 30, 2026