FDA 510(k) Applications Submitted by Ormco Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K203737 12/22/2020 Spark Clear Aligner System Ormco Corporation
K250487 02/19/2025 SparkTM Clear Aligner System Ormco Corporation
K240501 02/21/2024 SparkÖ Clear Aligner System Ormco Corporation
K250015 01/02/2025 OrmcoÖ EtchFree Bonding System, OrmcoÖ EtchFree Bonding Primer, OrmcoÖ EtchFree Adhesive Ormco Corporation
K171844 06/20/2017 Inspire ICE aka Inspire ICE Clear Brackets Ormco Corporation
K172845 09/19/2017 Symetri Clear Ormco Corporation


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