Data / Medical devices / United Kingdom / PSP Dental Co., Ltd.

PSP Dental Co., Ltd.: FDA-registered device maker in Belvedere, Kent, United Kingdom, 6 510(k) clearances

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

PSP Dental Co., Ltd. is registered with the FDA (registration 8021851) in Belvedere, Kent, United Kingdom. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 21, 1986. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 8021851
FEI number: 1000254146
Address: 3-5 Dylan RD., Belvedere, Kent, United Kingdom, DA17 5QS
Owner or operator: PSP DENTAL CO., LTD. (8021851)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: March 17, 1987
Registered through: 2026
Brand names listed: Alginamine, C&B Temp, Carbchem, Zinc Phosphate, Ceram II Powder/Liquid, Ceramchem, Ceramcore, Ceramfil ART Powder, Ceramfil B and more

Devices it lists

Device	Product code	Class	Role	Source
Cement, Dental	EMA	2	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Material, Impression	ELW	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Zinc Oxide Eugenol	EMB	1	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler	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
April 21, 1986	K853089	SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE	ELW	Substantially Equivalent	Psp Dental Co., Ltd.	accessdata.fda.gov
April 4, 1986	K853094	EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA	EBI	Substantially Equivalent	Psp Dental Co., Ltd.	accessdata.fda.gov
April 3, 1986	K853092	PSP C & B TEMP	EBG	Substantially Equivalent	Psp Dental Co., Ltd.	accessdata.fda.gov
January 21, 1986	K853091	CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE	EMA	Substantially Equivalent	Psp Dental Co., Ltd.	accessdata.fda.gov
January 21, 1986	K853090	CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO	EMA	Substantially Equivalent	Psp Dental Co., Ltd.	accessdata.fda.gov
September 6, 1985	K853093	PSP TEMP - TRAY	EBH	Substantially Equivalent	Psp Dental Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 21, 1986. 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.