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ClearVu Mini Ceramic Brackets

TP ORTHODONTICS INC · Model 297-495CV · UDI-DI 00192029005651

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

Description

Bi-Dimensional Brackets with Hooks 0.46 mm (.018") centrals and laterals with 0.56 mm (.022") cuspids and bicuspids, Bondable

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.