Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010175098

FEI Number

3010175098

Entity Name

CONVERGENT DENTAL

City/State/Country

Waltham, MA, US

Establishment Address

100 Fifth Avenue, Suite 1010, Waltham, MA 02451, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Convergent Dental (Owner Number: 10043517)

Owner / Operator Contact Address

100 Fifth Avenue, Suite 1010, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130420

PMA Number

N/A

All Registered Proprietary Names

Solea WatchPATONE Watch-PAT1 WatchPAT ONE WatchPAT-ONE WP1 Watch-PAT ONE WatchPAT ONE-M Probes Solea Solea Solea

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2023-02-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-12-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-01-03
NVK	Laser, Dental, Soft Tissue	General, Plastic Surgery	Class 2	878.4810	2023-01-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-02-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-07-17

Official Correspondent

Joe Coscia

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Convergent Dental

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010175098. Last updated year: 2026. Please use registration number 3010175098 when referencing this establishment in official correspondence.