Data / Medical devices / United States / Gurunanda LLC

Gurunanda LLC: FDA-registered device maker in Buena Park, CA, United States, 3 510(k) clearances

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

Gurunanda LLC is registered with the FDA (registration 3014468707) in Buena Park, CA, United States. It lists 16 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 22, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3014468707
Address: 6645 Caballero BLVD., Buena Park, CA, United States, 90620
Owner or operator: GURUNANDA LLC (10061329)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: October 11, 2019
Registered through: 2027
Brand names listed: COMFORTFLOW BOTTLE, DENTAL GURU CHARCOAL FLEXI PICKS, DENTALGURU KIDS PIXEL, GURUNANDA, GuruNanda Aligner and Retainer Cleaning Foam, GuruNanda Dry Mouth Oral Rinse, GuruNanda Dry Mouth Spray, GuruNanda Retainer & Denture Cleaning Pod and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Ent	KCJ	1	Repackager or relabeler	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Repackager or relabeler	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Eraser, Dental Stain	MAU	1	Repackager or relabeler	accessdata.fda.gov
Floss, Dental	JES	1	Repackager or relabeler	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Repackager or relabeler	accessdata.fda.gov
Irrigator, Powered Nasal	KMA	1	Repackager or relabeler	accessdata.fda.gov
Pick, Massaging	JET	1	Repackager or relabeler	accessdata.fda.gov
Respirator, Surgical	MSH	2	Repackager or relabeler	accessdata.fda.gov
Saliva, Artificial	LFD	U	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scraper, Tongue	LCN	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Repackager or relabeler	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Repackager or relabeler	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Repackager or relabeler, Specification developer	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
August 22, 2023	K231205	GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray	LFD	Substantially Equivalent	Gurunanda, LLC	accessdata.fda.gov
November 28, 2018	K180207	Non-contact Infrared Thermometer	FLL	Substantially Equivalent	Alicn Medical (Shenzhen), Inc.	accessdata.fda.gov
December 13, 2010	K102718	DIGITAL THERMOMETER; DIGITAL THERMOMETER	FLL	Substantially Equivalent	International Regulatory Consultants, LLC (Irc)	accessdata.fda.gov

Compare with other makers

Updated August 22, 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.