Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004046477

FEI Number

3004046477

Entity Name

Suzhou Pac-Dent Technology Co., Ltd

City/State/Country

SUZHOU CITY Jiangsu, CN

Establishment Address

Building 1: Floor 1, 2, 4 of Area A & Area C, Area B, Building 3, Building 5; 51 Zhousidun Road, Caohu Street, SUZHOU CITY Jiangsu 215000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Pac-Dent Inc. (Owner Number: 10056434)

Owner / Operator Contact Address

670 Endeavor Cir, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk 131118 EzAim ComforTab Adhesive Sensor Holder Bitewing Red, 50/pk 131117 EzAim Individually Cut Adhesive Sensor Holder Anterior White, 50/pk 131118 EzAim Individually Cut Adhesive Sensor Holder Bitewing Red, 50/pk 131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk 131120 EzAim Individually Cut Adhesive Sensor Holder Posterior Yellow, 50/pk 131119 EzAim Individually Cut Adhesive Sensor Holder Bitewing Blue, 50/pk 131116 EzAim Individually Cut Adhesive Sensor Holder Anterior Blue, 50/pk 131119 EzAim ComforTab Adhesive Sensor Holder Bitewing Blue, 50/pk 131120 EzAim ComforTab Adhesive Sensor Holder Posterior Yellow, 50/pk JS Dental Pac-Dent Disposable Tray, Tooth Whitening COMPOSITE SPATULAS PLASTIC EasyProp iMatrix Clear Dental barriers and sleeves Rodin TruModel ProAngle ProMate Freestyle Pro ProMateEZ-Q Quick Disconnect Coupler AntiSplatr Flex Slim disposable Prophy Angle Bulk Pack, 90 Degree, Flex Cup, 1,200ct AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ct ProMate EZ-Q Quick Disconnect Hygiene Handpiece ACCLEAN ERGO PROPHY ANGLE LF AntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ct AntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ct AntiSplatr Disposable Prophy Angles ProMate EZ-Q Quick Disconnect Combo- Hygiene Handpiece and Coupler PJ-01 ProJect Composite Dispensing Gun Air Techniques Pac-Dent Barrier Sleeve, Cover It Barrier Film UNIVERSAL CURING LIGHT SHIELD PSP Barrier Envelopes Pinnacle Sleeves, Covers, Sheaths, Cover-All, Allrap Protective Barriers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2017-12-14
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2017-12-11
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2017-12-21
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2017-12-14
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2017-12-21
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2017-12-21
EIG	Retractor, All Types	Dental	Class 1	872.4565	2017-12-14
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2017-12-14
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2017-12-29
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2017-12-14
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2017-12-21
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2018-06-08
DZM	Needle, Dental	Dental	Class 1	872.4730	2017-12-08
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2017-12-14
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2017-12-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2017-12-21
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2017-12-11
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2017-12-11
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2017-12-08
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2017-12-21
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2017-12-14
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2017-12-11
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2022-07-15

Official Correspondent

Nikki Huynh

US Agent Details

Heather Hang Business: Pac-Dent, Inc. Email: hang.m@pac-dent.com Phone: (909) 8390888

Related Public Records

Same Entity

Pac-Dent Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2086043	PAC-DENT INC.	Brea, CA, US
3015491448	iBrite Suzhou Technology Co., Ltd	SUZHOU CITY Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02

Similar Registrations

Registration Number	Establishment Name	Location
3016954909	IMPLANT PROTESIS DENTAL 2004, S.L.	Premia de Dalt Barcelona, ES
3005972890	GoldenDent	Roseville, MI, US
3008808049	SURGICRAFTS	Sialkot Punjab, PK
3010583458	ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, CN
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004046477. Last updated year: 2026. Please use registration number 3004046477 when referencing this establishment in official correspondence.