Diamante™ Mbt Ceramic Brackets

FDA UDI

Class II (US FDA UDI)

by G&H Wire Company, Inc.

Identity

Trade Name: DIAMANTE™ MBT CERAMIC BRACKETS FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: DIAMANTE™ MBT .022 UL2 +10°T +8°A Diamante™ ceramic brackets are transparent and nearly invisible as they composed of 99.9% pure polycrystalline alumina. They are impervious to stains and discoloration, helping them stay transparent for the duration of the treatment. Diamante™ ceramic brackets are small and smooth, with rounded corners that provide a comfort level to the patient. Diamante™ ceramic brackets features a unique state-of-the-art dovetail base design for maximum bonding surface between the bracket and the adhesive. Successful bonding and debonding can be achieved using currently available bonding techniques. FDA UDI
Model / Reference: 57-U2-2L-V FDA UDI
Description: DIAMANTE™ MBT .022 UL2 +10°T +8°A Diamante™ ceramic brackets are transparent and nearly invisible as they composed of 99.9% pure polycrystalline alumina. They are impervious to stains and discoloration, helping them stay transparent for the duration of the treatment. Diamante™ ceramic brackets are small and smooth, with rounded corners that provide a comfort level to the patient. Diamante™ ceramic brackets features a unique state-of-the-art dovetail base design for maximum bonding surface between the bracket and the adhesive. Successful bonding and debonding can be achieved using currently available bonding techniques. FDA UDI

Identifiers

Primary DI / UDI-DI: 10190886005644 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

Diamante™ Mbt 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.

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Experience — GC Orthodontics America Inc. · Class II
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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 0a8cd3f8-5bf1-40e9-bf38-5cd7446a0b6a 35 fields · synced Jun 8, 2026