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Vatech Clismile

Rayence Co., Ltd. · Model 11-1241 · UDI-DI 08800018601044

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510(k) clearances

Adverse events

Recalls

Facilities

Description

This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.

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.