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Insignia

ORMCO CORPORATION · Model 728-0075 · UDI-DI 00889989081671

NJM Prescription
10
510(k) clearances
23
Adverse events
1
Recalls
47
Facilities

Description

INSIGNIA U5-5 DAMON CLEAR/L3-3 DAMON CLEAR/SL SPK

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.