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FDA 510(k)

PSP C & B TEMP

K-Number: K853092 · 1986-04-03

ApplicantPsp Dental Co., Ltd.
Decision Date1986-04-03
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PSP C & B TEMP is the device name listed in this FDA 510(k) record. The listed applicant is Psp Dental Co., Ltd.. It received FDA 510(k) clearance on 1986-04-03 under 510(k) number K853092. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSP C & B TEMP?

PSP C & B TEMP is a medical device that received FDA 510(k) clearance on 1986-04-03. The listed applicant is Psp Dental Co., Ltd.. The 510(k) number is K853092.

When did PSP C & B TEMP receive FDA 510(k) clearance?

PSP C & B TEMP received FDA 510(k) clearance on 1986-04-03, under 510(k) number K853092.

Who is the listed applicant for PSP C & B TEMP?

The FDA 510(k) record lists Psp Dental Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSP C & B TEMP?

The FDA product code for PSP C & B TEMP is EBG.

Other records listing Psp Dental Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K853089SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREEK853094EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEAK853091CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATEK853090CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIOK853093PSP TEMP - TRAY

Related Devices (Code: EBG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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