Manufacturer registered with FDA
Psp Dental Co., Ltd.
BELVEDERE, KENT, United Kingdom. Lists 6 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 32
- 510(k) clearances
- 61985–1986
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1United Kingdom
510(k) clearances per year, 1980–2026
Registered in 3 markets
Where regulators' registries name Psp Dental Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Psp Dental Co., Ltd. | 6 clearances | 1985–1986 | Below |
| Egypt | EDA | Manufacturer | PSP Dental Co. Ltd,PSP Dental Co Ltd, | 4 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PSP DENTAL CO. LTD. | 2 | 2014–2021 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Psp Dental Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | Carbchem, Zinc PhosphateCeram II Powder/LiquidCeramchemCeramcoreCeramfil ART PowderCeramfil BCeramfil B SeasonsCeramfil Molar Powder/LiquidFlorionFluricem 5 moreGlass Ionomer Filling MaterialGlass Ionomer filling Material (Powder/Liquid)Glass Ionomer Filling Material for Anterior Tooth (Powder/Liquid)Glass Ionomer filling material for deciduous teeth (Atraumatic Restorative Technique)Straticem | 2007 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | C&B TempNucavfil | 2007 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Temp Tray | 2007 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Emperor 5/20Emperor CCEmperor Comf-DentEmperor ComfdentEmperor OrthoEmperor PerisealEmperor RefitEmperor Std | 2007 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | AlginamineOrtho AlginPro Algin Chromatic AlginatePSP Super AlginSuper Algin | 2007 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | TEMPLIN, TEMP D, NUCAVFIL | 1987 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Psp Dental Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Apr 1986 | K853089 | SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE | ELW Impression Material |
| 4 Apr 1986 | K853094 | EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA | EBI Rebasing Repairing Relining Denture Resin |
| 3 Apr 1986 | K853092 | PSP C & B TEMP | EBG Resin Temporary Crown and Bridge |
| 21 Jan 1986 | K853091 | CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE | EMA Dental Cement |
| 21 Jan 1986 | K853090 | CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO | EMA Dental Cement |
| 6 Sep 1985 | K853093 | PSP TEMP - TRAY | EBH Resin Impression Tray Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PSP DENTAL CO., LTD.FDA reg. 8021851 | BELVEDERE, KENT, United Kingdom | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8021851). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.