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HomeG & H Wire Company, Inc. › CLARION™ ROTH METAL-LINED CERAMIC BRACKETS

CLARION™ ROTH METAL-LINED CERAMIC BRACKETS

G & H Wire Company, Inc. · Model 50-U2-8L-V · UDI-DI 10190886003404

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

Description

CLARION™ ROTH .018 UL2 +8°T +9°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.

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.