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Tip Edge Comb Non-Convertible Molar Tube

TP ORTHODONTICS INC · Model 391-908 · UDI-DI 00192029013151

DZD

510(k) clearances

Adverse events

Recalls

114

Facilities

Description

UR 1st Molar Torque -11, Tip 0, Distal Offset Rect & Rnd 6 0.56 mm x 0.71 mm (.022" x .028") 4.7 mm

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.