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ATOZ-Tooth Connection Arms

MK Meditech Inc. · Model MK-Wire arm-1240 · UDI-DI 08800197900044

DZC Prescription

510(k) clearances

328

Adverse events

Recalls

171

Facilities

Description

PRODUCT SUMMARY This is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement. TRADE NAME ATOZ Wire arm * 4EA MODEL NAME MK Wire arm-1240 INDICATION FOR USE This can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement with bending the wire arm various shape according to the treatment plan. PRODUCT MATERIAL 316L Stainless Steel CONSIST OF: MK-Wire arm-1240*4ea

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.