Psp Dental Co., Ltd.
United KingdomFDA applicant, unverified FDA FEI 1000254146
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Psp Dental Co., Ltd. makes
Psp Dental Co., Ltd. manufactures dental impression materials, including temporary and custom-fit trays (e.g., PSP TEMP - TRAY, PSP REFIT), orthodontic products (e.g., ORTHO), and alginate-based impression compounds (e.g., SUPER ALGIN, ALGINAMINE). The company also produces dental cements and adhesives, such as CARDCHEM AQUASET and CERAMCHEM, as well as fluoride-releasing agents like FLURICEM and FLORIO. Additional offerings include dental stone and investment materials (e.g., CERAMFIL B, STRATICEM) and a dust-free impression powder (EMPRESS DUSTFREE).
These products are classified under Class I and Class II regulatory categories, with relevant devices authorised via the FDA’s 510(k) pathway. The company is based in the United States and its devices are listed in the FDA’s 510(k) registry for compliance tracking.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Psp C & B Temp Ref K853092
Regimes: 510(k) Registry: 510(k)Psp Temp - Tray Ref K853093
Regimes: 510(k) Registry: 510(k)Cardchem Aquaset, Temp D, Templin, 2N Phosphate Ref K853091
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Super Algin, Alginamine, Empress Dustfree Ref K853089
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000254146
- Address
- 3-5 DYLAN RD., BELVEDERE, KENT
Frequently asked questions
How many devices does Psp Dental Co., Ltd. have in the registry?
The registry currently lists 6 devices for Psp Dental Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Psp Dental Co., Ltd.'s devices?
Among its 6 most recently registered devices, Psp Dental Co., Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Psp Dental Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Psp Dental Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Psp Dental Co., Ltd. in the registry?
The most recently registered devices listed for Psp Dental Co., Ltd. include EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA, PSP C & B TEMP, PSP TEMP - TRAY and CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE.