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iBrite Suzhou Technology Co., Ltd: FDA-registered device maker in SUZHOU CITY Jiangsu, China, 1 510(k) clearance

Name: iBrite Suzhou Technology Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

iBrite Suzhou Technology Co., Ltd is registered with the FDA (registration 3015491448) in SUZHOU CITY Jiangsu, China. It lists 18 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 3, 2016. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3015491448
Address: 51 Zhousidun road, SUZHOU CITY Jiangsu, China, 215100
Owner or operator: Pac-Dent Inc. (10056434)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler
First device listed: December 8, 2017
Registered through: 2027
Brand names listed: 131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk, 131116 EzAim Individually Cut Adhesive Sensor Holder Anterior Blue, 50/pk, 131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk, 131117 EzAim Individually Cut Adhesive Sensor Holder Anterior White, 50/pk, 131118 EzAim ComforTab Adhesive Sensor Holder Bitewing Red, 50/pk, 131118 EzAim Individually Cut Adhesive Sensor Holder Bitewing Red, 50/pk, 131119 EzAim ComforTab Adhesive Sensor Holder Bitewing Blue, 50/pk, 131119 EzAim Individually Cut Adhesive Sensor Holder Bitewing Blue, 50/pk and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Contract manufacturer	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Contract manufacturer	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Contract manufacturer	accessdata.fda.gov
Collimator, X-Ray	EHB	1	Contract manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Contract manufacturer	accessdata.fda.gov
Dental Barriers And Sleeves	PEM	2	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Contract manufacturer	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Contract manufacturer	accessdata.fda.gov
Needle, Dental	DZM	1	Contract manufacturer	accessdata.fda.gov
Retainer, Matrix	JEP	1	Contract manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Contract manufacturer	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Contract manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Contract sterilizer	accessdata.fda.gov
Tray, Fluoride, Disposable	KMT	1	Contract manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Contract manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Contract manufacturer	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 3, 2016	K151123	Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film	PEM	Substantially Equivalent	Pac-Dent International, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 3, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.