Ortho Organizers, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
8
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2477-2020Class IIMaestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484April 2, 2019
Z-2478-2020Class IIMaestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 MApril 2, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K252760Carriere® Motion Pro® Clear Bite CorrectorNovember 27, 2025
K173440Carriere SLX 3D ClearMarch 8, 2018
K160720Carriere Motion Clear Class IINovember 28, 2016
K110335CERAMIC BRACKETSMay 19, 2011
K061266ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHORJuly 31, 2006
K923218NITANIUM PALATAL EXPANDERSeptember 13, 1993
K931980STAINLESS STEEL ORTHODONTIC PRODUCTSSeptember 1, 1993
K931663NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGULJuly 8, 1993