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FDA 510(k)

EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA

K-Number: K853094 · 1986-04-04

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

Device Summary

EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA 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 1986-04-04 under 510(k) number K853094. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA?

EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA is a medical device that received FDA 510(k) clearance on 1986-04-04. The listed applicant is Psp Dental Co., Ltd.. The 510(k) number is K853094.

When did EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA receive FDA 510(k) clearance?

EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA received FDA 510(k) clearance on 1986-04-04, under 510(k) number K853094.

Who is the listed applicant for EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA?

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 EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA?

The FDA product code for EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA is EBI.

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 DUSTFREEK853092PSP C & B TEMPK853091CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATEK853090CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIOK853093PSP TEMP - TRAY

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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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