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Convergent Dental

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0324-2024Class IISolea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CSeptember 1, 2023
Z-0050-2014Class IISolea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.September 12, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K221761SoleaSeptember 14, 2022
K151306SoleaSeptember 23, 2015
K130420SOLEAJuly 12, 2013
K123494SOLEAFebruary 11, 2013