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ZENITH™ ROTH CERAMIC BRACKETS (KIT)

G & H Wire Company, Inc. · Model KTRCR2255XA · UDI-DI 10190886010686

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510(k) clearances

Adverse events

Recalls

Facilities

Description

ZENITH™ ROTH CRMC 5-5 KIT 022 X10 Zenith™ Series Ceramic [CR] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.

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.