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Ormco Corporation

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories3
Latest FDA decision2025-02-20
TypeNumberDevice NameCodeDateActions
510(k) K250487 SparkTM Clear Aligner SystemNXC2025-02-20 View
510(k) K250015 Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveDYH2025-01-03 View
510(k) K240501 Spark™ Clear Aligner SystemNXC2024-10-11 View
510(k) K203737 Spark Clear Aligner SystemNXC2021-03-22 View
510(k) K172845 Symetri ClearNJM2018-01-31 View
510(k) K171844 Inspire ICE aka Inspire ICE Clear BracketsNJM2017-07-18 View
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