Data / Medical devices / United States / Dentlight Inc.

Dentlight Inc.: FDA-registered device maker in Plano, TX, United States, 4 510(k) clearances

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

Dentlight Inc. is registered with the FDA (registration 3005515469) in Plano, TX, United States. It lists 10 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 26, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005515469
Address: 1825 Summit Ave Ste 210, Plano, TX, United States, 75074
Owner or operator: DENTLIGHT INC. (9077801)
Roles: Manufacturer, Remanufacturer
First device listed: December 19, 2005
Registered through: 2026
Brand names listed: DOE, DOE SE, Dentlight Oral Exam Light Kit, FUSION Curing Light, FUSION PBM, FUSION Plus-Grand Curing Light, FUSION-DOE, Nano Loupe Light and more

Devices it lists

Device	Product code	Class	Role	Source
Activator, Ultraviolet, For Polymerization	EBZ	2	Manufacturer	accessdata.fda.gov
Camera, Television, Surgical, With Audio	FWC	1	Manufacturer	accessdata.fda.gov
Detector, Ultraviolet	EAQ	2	Manufacturer	accessdata.fda.gov
Diagnostic Light, Soft Tissue Detector	NXV	2	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Laser, Dental, Soft Tissue	NVK	2	Manufacturer	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Manufacturer	accessdata.fda.gov
Light, Surgical Headlight	EBA	1	Manufacturer	accessdata.fda.gov
Loupe, Diagnostic/Surgical	FSP	1	Manufacturer, Remanufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	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
February 26, 2021	K201387	Ultrafast, Ultrafast Plus, Ultrafast Lite	NVK	Substantially Equivalent	Dentlight, Inc.	accessdata.fda.gov
April 19, 2019	K180065	FUSION Plus Curing Light	EBZ	Substantially Equivalent	Dentlight, Inc.	accessdata.fda.gov
July 15, 2010	K101140	DENTLIGHT ORAL EXAM LIGHT KIT	NXV	Substantially Equivalent	Dentlight, Inc.	accessdata.fda.gov
September 28, 2005	K052593	FUSION CURING LIGHT	EBZ	Substantially Equivalent	Dentlight, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 26, 2021. 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.