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DIAMANTE™ ROTH CERAMIC BRACKETS

G & H Wire Company, Inc. · Model 55-U3-8RK-V · UDI-DI 10190886004692

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Description

DIAMANTE™ ROTH .018 UR3 HK 0°T +11°A 4°R 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.

Recalls

Date	Firm	Reason
2013-11-19	Ultradent Products, Inc.	Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.