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Q.C.M.Retainer Wire

CHIKAMI MILTEC INC. · Model RWL-P36 · UDI-DI 04570077940128

DZC

510(k) clearances

328

Adverse events

Recalls

171

Facilities

Description

"This product can be used to make a very aesthetic retainer called ""Q.C.M. Retainer"". The Q.C.M.Retainer is not only crystal clear, but also has a 3 mm width of the plastic resin part, which is excellent for maintaining torque. Furthermore, it can be made with a very simple operation."

Recalls

Date	Firm	Reason
2015-11-04	Ormco/Sybronendo	Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
2013-12-13	Highland Metals, Inc.	Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark
2013-12-13	Highland Metals, Inc.	Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark
2011-03-15	Ormco Corporation	The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007.

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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.