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FDA 510(k)

PROPHY CARE SOLUTION

K-Number: K865082 · 1987-02-12

ApplicantImd, Inc.
Decision Date1987-02-12
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROPHY CARE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Imd, Inc.. It received FDA 510(k) clearance on 1987-02-12 under 510(k) number K865082. 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 PROPHY CARE SOLUTION?

PROPHY CARE SOLUTION is a medical device that received FDA 510(k) clearance on 1987-02-12. The listed applicant is Imd, Inc.. The 510(k) number is K865082.

When did PROPHY CARE SOLUTION receive FDA 510(k) clearance?

PROPHY CARE SOLUTION received FDA 510(k) clearance on 1987-02-12, under 510(k) number K865082.

Who is the listed applicant for PROPHY CARE SOLUTION?

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

What is the FDA product code for PROPHY CARE SOLUTION?

The FDA product code for PROPHY CARE SOLUTION 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 Imd, 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.

K113662FENESTRATED NERVE BLOCK NEEDLEK864215PROPHY CARE SOLUTIONK863133PROPHY CARE PASTE

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

View on FDA Database →

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

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