Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021368823

FEI Number

3021368823

Entity Name

QIBEI TECHNOLOGY CO., LIMITED

City/State/Country

KL Hong Kong, CN

Establishment Address

RM 2914,29/F HO KING COMM CTR 2-16 FA YUEN ST MONGKOK, KL Hong Kong 999077, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

QIBEI TECHNOLOGY CO., LIMITED (Owner Number: 10091805)

Owner / Operator Contact Address

RM 2914,29/F HO KING COMM CTR 2-16 FA YUEN ST MONGKOK, KL, CN-HK 999077, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental operating lamp LD01,LD02,LD03,LD05,LD06 TBX01,TBX02,TBX03,TBX04,TBX05,TBX06,TBX07,TBX08 Toothbrush sterilizer Electric toothbrush and electric toothbrush replacement head WP02,WP03,WP04,WP05,WP06,PPF1,CT01,CT02,BT101,BT102,BT103,BT104,BT105,BT106,BT107,BT108,BT109 OT100,OT101,OT102,OT103,OT105,OT106 Orthodontic appliances and accessories Oral irrigator and replacement nozzle for irrigator Dental lrigator and irigator replacement nozzles H1S,H2S,H3S,H5S,JT100E,JT100,DT100E,OD100E,PP100E,PS100E,TB100E,TC100E,CL100,NW100,BT100,QA100,WF01,WF02,WF03 TB11 TB12,TB13,TB15,TB16,TB17,TB18,TB19,TB20,TB21,TB22 201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218, 301,302,303,304,305,306,307,308,309,310,311,312 Manual toothbrush 719, 8803, 812,9005,7102,826,702,OT01,OT02 101,102,103,104,105,106,107,108,109,111,112,113,114,115,116,117,118,119 313,314,315,316,317,318,319,320,321,322,323,324,325,326,327 TB01,TB02,TB03,TB04,TB05,TB06,TB07,TB08,TB09,TB10 NJ01,NJ02,NJ03,NJ04,NJ05,NJ06,NJ07,NJ08,NJ09,NJ10 External nasal splint NC01,NC02,NC03,NC04,NC05,NC06,NC07,NC08,NC09,NC10 Powered nasal irrigator Used for oral hygiene or tip K01,K02,K03,K05,K06,K07,K08 HC01,HC02,HC03,HC04 Mouth guard Dental protector YJ01,YJ02,YJ03,YJ04,YJ05,YJ06,YJ07,YJ08,YJ09,YJ10 YB01,YB02,YB03,YB04,YB05,YB06,YB07,YB08,YB09,YB10 Braces bite glue Dental handheld instruments MT01,MT02,MT03,MT05,MT06 Oral product storage appliances Toothbrush travel container OR01,OR02,OR03,OR04,OR05,SN06,SN07,SN08,SN09 TBC01,TBC02,TBC03,TBC04,TBC05,TBC06,TBC07,TBC08

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2024-11-04
MCF	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile	Dental	Class 1	872.6855	2024-11-04
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2024-11-04
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2024-11-04
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-11-04
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2024-11-04
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	2024-11-04
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2024-11-04
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2024-11-04
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2024-11-04
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-11-04
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2024-11-04

Official Correspondent

Jim Luo

US Agent Details

Emilie Davis Business: Mars Register Agent LLC Email: safjiofewiwds@wilson.ntesmail.com Phone: (805) 5797288

Related Public Records

Same Entity

QIBEI TECHNOLOGY CO., LIMITED

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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021368823. Last updated year: 2026. Please use registration number 3021368823 when referencing this establishment in official correspondence.