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N/A

Flexmedics · Model 50K-3-18-01 · UDI-DI 10195291004091

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

Description

Metal Lined Cermic Twin ROTH .018 HK/3 METAL-LINED CERAMIC W/CASE

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.