Data / Medical devices / United States / Convergent Dental

Convergent Dental: FDA-registered device maker in Waltham, MA, United States, 4 510(k) clearances

Name: Convergent Dental FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Convergent Dental is registered with the FDA (registration 3010175098) in Waltham, MA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 14, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010175098
Address: 100 Fifth Avenue Suite 1010, Waltham, MA, United States, 02451
Owner or operator: Convergent Dental (10043517)
Roles: Manufacturer
First device listed: February 22, 2013
Registered through: 2026
Brand names listed: Solea, WP1, Watch-PAT ONE, Watch-PAT1, WatchPAT ONE, WatchPAT ONE-M Probes, WatchPAT-ONE, WatchPATONE

Devices it lists

Device	Product code	Class	Role	Source
Laser, Dental, Soft Tissue	NVK	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 14, 2022	K221761	Solea	NVK	Substantially Equivalent	Convergent Dental, Inc.	accessdata.fda.gov
September 23, 2015	K151306	Solea	GEX	Substantially Equivalent	Convergent Dental, Inc.	accessdata.fda.gov
July 12, 2013	K130420	SOLEA	GEX	Substantially Equivalent	Convergent Dental, Inc.	accessdata.fda.gov
February 11, 2013	K123494	SOLEA	GEX	Substantially Equivalent	Convergent Dental, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 1, 2023	93203	Class II	Ongoing	Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked	It has been found that potential unintended laser activation can occur without foot pedal depression.	accessdata.fda.gov
September 12, 2013	66361	Class II	Terminated	Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.	Specific error condition could lead to unintended laser emission during laser activation.	accessdata.fda.gov

Compare with other makers

Updated November 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.