Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014468707

FEI Number

3014468707

Entity Name

GURUNANDA LLC

City/State/Country

Buena Park, CA, US

Establishment Address

6645 CABALLERO BLVD., Buena Park, CA 90620, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

GURUNANDA LLC (Owner Number: 10061329)

Owner / Operator Contact Address

6645 CABALLERO BLVD., Buena Park, CA 90620, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-contact Infrared Forehead Thermometer GURUNANDA TruMed Digital Thermometer MENTADENT WHITENING COMFORTFLOW BOTTLE NETI POT GuruNanda Retainer & Denture Cleaning Pod Gurunanda Disposable Face Mask DENTALGURU KIDS PIXEL GuruNanda Dry Mouth Oral Rinse GuruNanda Dry Mouth Spray DENTAL GURU CHARCOAL FLEXI PICKS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-06-01
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2019-12-13
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2024-03-07
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2022-04-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-09-20
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2021-06-06
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2020-07-03
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-08-27
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2022-12-29
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-09-16
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2019-10-11
LFD	Saliva, Artificial	Unknown	Class U	N/A	2026-01-12
JES	Floss, Dental	Dental	Class 1	872.6390	2019-10-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GURUNANDA LLC

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014468707. Last updated year: 2026. Please use registration number 3014468707 when referencing this establishment in official correspondence.