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FDA 510(k)

PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE

K-Number: K962370 · 1997-03-31

ApplicantChallenge Products, Inc.
Decision Date1997-03-31
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE 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 1997-03-31 under 510(k) number K962370. 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 PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE?

PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE is a medical device that received FDA 510(k) clearance on 1997-03-31. The listed applicant is Challenge Products, Inc.. The 510(k) number is K962370.

When did PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE receive FDA 510(k) clearance?

PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE received FDA 510(k) clearance on 1997-03-31, under 510(k) number K962370.

Who is the listed applicant for PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE?

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 PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE?

The FDA product code for PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE 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.

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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.

K940496PROPHY PASTEK884245PERFECT 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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