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FDA 510(k)

CUPRIDENT

K-Number: K851073 · 1985-07-31

ApplicantBio Systems, Inc.
Decision Date1985-07-31
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CUPRIDENT is the device name listed in this FDA 510(k) record. The listed applicant is Bio Systems, Inc.. It received FDA 510(k) clearance on 1985-07-31 under 510(k) number K851073. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUPRIDENT?

CUPRIDENT is a medical device that received FDA 510(k) clearance on 1985-07-31. The listed applicant is Bio Systems, Inc.. The 510(k) number is K851073.

When did CUPRIDENT receive FDA 510(k) clearance?

CUPRIDENT received FDA 510(k) clearance on 1985-07-31, under 510(k) number K851073.

Who is the listed applicant for CUPRIDENT?

The FDA 510(k) record lists Bio Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUPRIDENT?

The FDA product code for CUPRIDENT is EJR.

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 Bio Systems, Inc. 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.

K812582CANCEL

Related Devices (Code: EJR)

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.

K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.AK121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.K103114OSSPRAY SYLC CROsspray, Ltd.K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTESunstar Americas, Inc.K101104REMIN PROVoco GmbHK100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, 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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