Translex

FDA UDI

Class II (US FDA UDI)

by Ortho Pro Dent LLC

Identity

Trade Name: TRANSLEX FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: Orthodontic Ceramic brackets, Roth, slot .018" , Hooks on 3,4,5 FDA UDI
Model / Reference: 801R-WH FDA UDI
Description: Orthodontic Ceramic brackets, Roth, slot .018" , Hooks on 3,4,5 FDA UDI

Identifiers

Primary DI / UDI-DI: 00810152820773 FDA UDI
FDA Product Code: NJM FDA UDI
GMDN Term: Orthodontic bracket, ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5470 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic bracket, ceramic

Translex by Ortho Pro Dent LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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APC™ II Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
EXPERIENCE® — GC Orthodontics America Inc. · Class II
APC™ PLUS Clarity™ SL — 3M UNITEK CORPORATION · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Ortho Pro Dent LLC

Sources (1)

FDA UDI 1bf3a60a-8f59-41a1-8821-bd66a724c9a5 35 fields · synced May 31, 2026