Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010162782

FEI Number

3010162782

Entity Name

PROVIDENCE ENTERPRISE LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

101 Building 8 (Buildings 8,3,7,2,4,1) No.5-4 Neihuan Road, Shanxia Community, Pinghu Street, Longgang District, Shenzhen Guangdong 518111, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PROVIDENCE ENTERPRISE LTD. (Owner Number: 9057840)

Owner / Operator Contact Address

6/F,UNIT13-15,GRAND CITY PLAZA, NO.1 SAI LAU KOK ROAD,, TSUEN WAN, HONG KONG, HK-NOTA 230, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Waterpik Whitening Professional Water Flosser Waterpik Radiance Water Flosser Waterpik Whitening Water Flosser Waterpik Ultra Plus Water Flosser Waterpik Complete Care Sensonic WaterPik Traveler Water Flosser Waterpik Cordless Water Flosser Waterpik Classic Water Flosser WaterPik Implant Denture Tip Waterpik Sonic Fusion 2 Professional Water Flosser Waterpik Nano Water Flosser WaterPik Classic Jet Tip Waterpik Cordless Advanced 2 Water Flosser Waterpik Ion Professional Water Flosser Waterpik Cordless Pearl Water Flosser Waterpik Ion Water Flosser Waterpik Sonic Fusion Water Flosser Waterpik Ultra Professional Water Flosser Waterpik Sidekick Water Flosser WaterPik Cordless Advanced Water Flosser Waterpik Cordless Select Water Flosser Waterpik Cordless Freedom Water Flosser Waterpik Cordless Express Water Flosser Waterpik Ultra Water Flosser Waterpik Cordless Slide Water Flosser Waterpik Cordless Plus Water Flosser Waterpik Evolution Water Flosser Waterpik Aquarius Water Flosser Meibomian gland evaluator Disposable Insulin Delivery Device DUAL PUMP Pack Activator II (Disposable) Model LFD-2100 I-Grow VERITAS Swivel Handpiece VERITAS Advanced Fluidics Pack and Advanced Infusion Pack VERITAS Phacoemulsification Console VERITAS Remote Control VERITAS Advanced Foot Pedal Relion Waterpik Sensonic Toothbrush Waterpik Complete Care Sensonic Brush Head Waterpik Sensonic Brush Head Waterpik Complete Care Sensonic Renew Advanced Lancing Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2006-07-27
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-07-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-06-18
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2012-06-18
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-07-27
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	Class 2	886.5200	2023-07-27
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2013-04-30
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-07-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-02-17
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2006-07-27
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2013-07-14

Official Correspondent

Hong Hai Du

US Agent Details

Brett Freeman Email: bfreeman@providence-connect.com Phone: (949) 8518888

Related Public Records

Same Entity

PROVIDENCE ENTERPRISE LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007420876	Providence Enterprise (Ganzhou) Co., Ltd.	Ganzhou Jiangxi, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

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3006572778	IN'TECH INDUSTRIES	Ramsey, MN, US
3005607635	HI-P (XIAMEN) PRECISION PLASTIC MANUFACTURING CO.,	XIAMEN Fujian, CN
3014707731	NINGBO COOSKIN STATIONERY CO., LTD	Ningbo Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010162782. Last updated year: 2026. Please use registration number 3010162782 when referencing this establishment in official correspondence.