RegWardenFDA facility compliance records
Recall

Class II — Convergent Dental

Recalling firmConvergent Dental
Registered facilityCONVERGENT DENTAL (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonSpecific error condition could lead to unintended laser emission during laser activation.
ProductSolea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Quantity5
DistributionUS distribution including states of: MA, CT, NY.
Initiated2013-09-12
Classified2013-10-22
Terminated2013-11-15
Recall numberZ-0050-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Convergent Dental (Z-0050-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66361/

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