FDA Device Intelligence
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CERAMIC BRACKET ICERAM ROTH 0.018 - U1L(21) - 1UN

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA · Model 10.80.1121 · UDI-DI 07898488902465

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

Description

CERAMIC BRACKET ICERAM ROTH 0.018 - U1L(21) - 1UN

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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.