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FDA 510(k)

CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO

K-Number: K853090 · 1986-01-21

ApplicantPsp Dental Co., Ltd.
Decision Date1986-01-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO 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 1986-01-21 under 510(k) number K853090. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO?

CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Psp Dental Co., Ltd.. The 510(k) number is K853090.

When did CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO receive FDA 510(k) clearance?

CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO received FDA 510(k) clearance on 1986-01-21, under 510(k) number K853090.

Who is the listed applicant for CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO?

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 CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO?

The FDA product code for CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO is EMA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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, PERISEAK853092PSP C & B TEMPK853091CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATEK853093PSP TEMP - TRAY

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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