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HomeG & H Wire Company, Inc. › DIAMANTE™ MBT CERAMIC BRACKETS

DIAMANTE™ MBT CERAMIC BRACKETS

G & H Wire Company, Inc. · Model 57-U3-2R-V · UDI-DI 10190886005705

NJM Prescription
1
510(k) clearances
23
Adverse events
1
Recalls
47
Facilities

Description

DIAMANTE™ MBT .022 UR3 -7°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.

Recalls

DateFirmReason
2013-11-19Ultradent 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.