Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015491448

FEI Number

3015491448

Entity Name

iBrite Suzhou Technology Co., Ltd

City/State/Country

SUZHOU CITY Jiangsu, CN

Establishment Address

51 Zhousidun road, SUZHOU CITY Jiangsu 215100, 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

iMatrix Clear Pac-Dent SG AntiSplatr Disposable Prophy Angles 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 Pac-Dent Disposable Tray, Tooth Whitening

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2017-12-29
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2017-12-14
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2017-12-14
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-07-24
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2017-12-14
EHB	Collimator, X-Ray	Dental	Class 1	872.1840	2017-12-11
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2017-12-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2017-12-21
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2017-12-11
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2017-12-14
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2017-12-11
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2017-12-14
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2017-12-21
DZM	Needle, Dental	Dental	Class 1	872.4730	2017-12-08
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2017-12-21
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2017-12-21

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
3004046477	Suzhou Pac-Dent Technology Co., Ltd	SUZHOU CITY Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K781675	General X-Ray, Inc.	X-RAY COLLIMATOR	1978-12-04
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015491448. Last updated year: 2026. Please use registration number 3015491448 when referencing this establishment in official correspondence.