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Second Molar Single Tubes

TP ORTHODONTICS INC · Model 391-139 · UDI-DI 00192029019627

ECN
0
510(k) clearances
4
Adverse events
10
Recalls
105
Facilities

Description

LR 2nd Molar W/O Distal Extension Torque -25, Tip 0, Distal Offset 4 0.56 mm 0.71 mm (.022"x .028") 3.3 mm

Recalls

DateFirmReason
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

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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.