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TP Orthodontics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
5
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1787-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 maloccluMay 1, 2018
Z-1795-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 maloccluMay 1, 2018
Z-1792-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusMay 1, 2018
Z-1784-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusMay 1, 2018
Z-1793-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 maloccluMay 1, 2018
Z-1789-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 maloccluMay 1, 2018
Z-1783-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusMay 1, 2018
Z-1788-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 maloccluMay 1, 2018
Z-1791-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusMay 1, 2018
Z-1794-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 maloccluMay 1, 2018
Z-1790-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 maloccluMay 1, 2018
Z-1785-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusMay 1, 2018
Z-1786-2018Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusMay 1, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics EtOctober 14, 2022
K193385TP Orthodontics Clear Aligner SystemNovember 12, 2020
K111234CLICK-ITMay 13, 2011
K952643RIGHT-ON ADHESIVE BOUDING SYSTEMJuly 11, 1995
K950992CERAMAFLEX BRACKET SYSTEMMay 3, 1995