Clarion™ Roth Metal-Lined Ceramic Brackets

FDA UDI

Class II (US FDA UDI)

by G&H Wire Company, Inc.

Identity

Trade Name: CLARION™ ROTH METAL-LINED CERAMIC BRACKETS FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: CLARION™ ROTH .022 LO4 -17°T 0°A Clarion™ ceramic brackets feature a nickel-free silver alloy-lined archwire slot, making them a safe alternative for nickel sensitive patients. The metal slot is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The Clarion™ ceramic bracket system also features a state-of-the art dovetail base design for maximum bonding surface between the bracket and adhesive. Successful bonding and debonding can be achieved using currently available bonding techniques. FDA UDI
Model / Reference: 50-L4-2U-V FDA UDI
Description: CLARION™ ROTH .022 LO4 -17°T 0°A Clarion™ ceramic brackets feature a nickel-free silver alloy-lined archwire slot, making them a safe alternative for nickel sensitive patients. The metal slot is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The Clarion™ ceramic bracket system also features a state-of-the art dovetail base design for maximum bonding surface between the bracket and adhesive. Successful bonding and debonding can be achieved using currently available bonding techniques. FDA UDI

Identifiers

Primary DI / UDI-DI: 10190886003268 FDA UDI
510(k) Number: K132368 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic bracket, ceramic

Clarion™ Roth Metal-Lined Ceramic Brackets by G&H Wire Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket, ceramic.

NeoCrystal Plus — Ortho Organizers, Inc. · Class II
Ceramic/Metal Combination Kits — TP ORTHODONTICS, INC. · Class II
TipEdge PLUS Ceramic Readi-Base Bracket — TP ORTHODONTICS, INC. · Class II
Experience — GC Orthodontics America Inc. · Class II
Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
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

Cleared under the same submission

K132368 also covers:

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: G&H Wire Company, Inc.

Sources (1)

FDA UDI 255e6647-fa28-4f3b-bf42-cc58dc78bd0a 35 fields · synced Jun 8, 2026