Ormco Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250487SparkTM Clear Aligner SystemFebruary 20, 2025
K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveJanuary 3, 2025
K240501Spark™ Clear Aligner SystemOctober 11, 2024
K203737Spark Clear Aligner SystemMarch 22, 2021
K172845Symetri ClearJanuary 31, 2018
K171844Inspire ICE aka Inspire ICE Clear BracketsJuly 18, 2017