Home › G & H Wire Company, Inc. › LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS

LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS

G & H Wire Company, Inc. · Model 40-U3-8L-V · UDI-DI 10190886001059

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510(k) clearances

Adverse events

Recalls

Facilities

Description

LUCENT™ ROTH .018 UL3 0°T +11°A 4°R Lucent™ composite brackets feature a nickel-free silver alloy-lined archwire slot that makes them a safe alternative for nickel sensitive patients. The metal liner is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. 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. Lucent™ brackets feature a distinctively designed mushroom grooved base for increased surface contact, allowing for excellent adhesion. The brackets are designed with a porous coating that provides millions of additional undercuts that firmly grip the adhesive. As a result, additional primer agents are not required to bond Lucent™ brackets to the tooth's enamel. Lucent™ brackets feature superior retention and easy debonding characteristics.

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.