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Phoenix Optimal

PHOENIX ORTHODONTICS INC · Model D-80010-245B · UDI-DI 05060772890129

DZD Prescription

510(k) clearances

Adverse events

Recalls

114

Facilities

Description

OPTIMAL MBT .022 BOND BUCCAL TUBE SGL CONVERT L R 6 -20T:0A PK10

Recalls

Date	Firm	Reason
2020-01-17	Ormco/Sybronendo	The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal
2020-01-17	Ormco/Sybronendo	The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal
2013-03-08	Ormco/Sybronendo	Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correct
2010-11-01	Ortho Organizers Inc	Products were mis-labeled as nickel free.

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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.