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FDA 510(k)

PROPHY PASTE

K-Number: K940496 · 1994-04-19

ApplicantChallenge Products, Inc.
Decision Date1994-04-19
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROPHY PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Challenge Products, Inc.. It received FDA 510(k) clearance on 1994-04-19 under 510(k) number K940496. 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 PASTE?

PROPHY PASTE is a medical device that received FDA 510(k) clearance on 1994-04-19. The listed applicant is Challenge Products, Inc.. The 510(k) number is K940496.

When did PROPHY PASTE receive FDA 510(k) clearance?

PROPHY PASTE received FDA 510(k) clearance on 1994-04-19, under 510(k) number K940496.

Who is the listed applicant for PROPHY PASTE?

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

What is the FDA product code for PROPHY PASTE?

The FDA product code for PROPHY PASTE 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 Challenge Products, 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.

K962370PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDEK884245PERFECT CHOICEK853248CHALLENGER SUNRISE

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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