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PRISM™ ROTH COMPOSITE BRACKET

G & H Wire Company, Inc. · Model 45-L3-2R-V · UDI-DI 10190886002001

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510(k) clearances

Adverse events

Recalls

Facilities

Description

PRISM™ ROTH .022 LR3 -11°T +5°A 2°R Prism™ composite brackets. Not only are Prism™ composite brackets nearly invisible, but also the special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets.

Recalls

Date	Firm	Reason
2014-03-25	Ormco/Sybronendo	Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is m
2011-05-18	Ormco Corporation	Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
2011-05-18	Ormco Corporation	Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
2005-11-03	Ormco Corporation	Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
2005-11-03	Ormco Corporation	Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.

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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.