Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021851

FEI Number

1000254146

Entity Name

PSP DENTAL CO., LTD.

City/State/Country

BELVEDERE, KENT, GB

Establishment Address

3-5 DYLAN RD., BELVEDERE, KENT DA17 5QS, GB

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

PSP DENTAL CO., LTD. (Owner Number: 8021851)

Owner / Operator Contact Address

3-5 DYLAN RD., --, BELVEDERE, KENT, GB-NOTA DA17 5QS, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K853090

PMA Number

N/A

All Registered Proprietary Names

Temp Tray Nucavfil C&B Temp Ceram II Powder/Liquid Glass Ionomer Filling Material for Anterior Tooth (Powder/Liquid) Ceramfil B Seasons Ceramfil ART Powder Glass Ionomer Filling Material Fluricem Florion Ceramchem Straticem Ceramfil B Ceramcore Ceramfil Molar Powder/Liquid Glass Ionomer filling Material Glass Ionomer filling material for deciduous teeth (Atraumatic Restorative Technique) Glass Ionomer filling Material (Powder/Liquid)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2007-12-31
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-12-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-31

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

PSP DENTAL CO., LTD.

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
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Similar Registrations

Registration Number	Establishment Name	Location
3010622180	MEGA-PHYSIK Ges. fuer physikalische Messtechnik mbh Co KG	Rastatt Baden-Wurttemberg, DE
3009509745	DENT A PHARM PRODUKTIONSGESELLSCHAFT MBH	Barmstedt Schleswig-Holstein, DE
2411056	BUFFALO DENTAL MFG. CO., INC.	SYOSSET, NY, US
1417846	FRICKE DENTAL MFG. CO.	Streamwood, IL, US
3016447764	DSI DENTAL SOLUTIONS LTD	Ashdod Southern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021851. Last updated year: 2026. Please use registration number 8021851 when referencing this establishment in official correspondence.