Facility

CONVERGENT DENTAL

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010175098
Establishment type	Manufacture Medical Device
Location	100 Fifth Avenue Waltham, MA, US 02451
Registration status	Active · expires 2026
Parent company	Convergent Dental (owner-operator 10043517)
Brand names	Solea

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IIOngoing2023-09-01
It has been found that potential unintended laser activation can occur without foot pedal depression.
Class IITerminated2013-09-12
Specific error condition could lead to unintended laser emission during laser activation.

FDA inspections (1)

NAI2017-04-18
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Convergent Dental

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

Cite this record

RegWarden. “CONVERGENT DENTAL (FEI 3010175098) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010175098-convergent-dental/

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