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Single W/ Vertical Slot
TP ORTHODONTICS INC · Model 391-123 · UDI-DI 00192029019542
0
510(k) clearances
4
Adverse events
10
Recalls
105
Facilities
Description
UR 2nd Molar W/Distal Extension Torque -10, Tip 0, Distal Offset 14 0.46 mm 0.64 mm (.018"x .025") 4.0 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty 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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Get your free API keyRead the docsData 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.