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CONVERGENT DENTAL

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Solea	Model 3.0	FDA UDI	Class II	Active
Solea	Model 2.0	FDA UDI	Class II	Active
Solea	K130420	FDA 510(k)	Class II	Active
Solea	K221761	FDA 510(k)	Class II	Active
Solea	K151306	FDA 510(k)	Class II	Active
Solea	K123494	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 1, 2023	Z-0324-2024	—	open, classified	It has been found that potential unintended laser activation can occur without foot pedal depression.
Sep 12, 2013	Z-0050-2014	—	terminated	Specific error condition could lead to unintended laser emission during laser activation.