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FDA 510(k)

RADENT PROPHY PASTE

K-Number: K040661 · 2004-06-09

ApplicantPascal Co., Inc.
Decision Date2004-06-09
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RADENT PROPHY PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Pascal Co., Inc.. It received FDA 510(k) clearance on 2004-06-09 under 510(k) number K040661. 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 RADENT PROPHY PASTE?

RADENT PROPHY PASTE is a medical device that received FDA 510(k) clearance on 2004-06-09. The listed applicant is Pascal Co., Inc.. The 510(k) number is K040661.

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

RADENT PROPHY PASTE received FDA 510(k) clearance on 2004-06-09, under 510(k) number K040661.

Who is the listed applicant for RADENT PROPHY PASTE?

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

What is the FDA product code for RADENT PROPHY PASTE?

The FDA product code for RADENT PROPHY PASTE is EJR.

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Other records listing Pascal Co., 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.

K102526BLO2X OXYGEN BLOCKERK090597FLUORILAQ SODIUM FLUORIDE CAVITY VARNISHK040988ZIRCON-F PROPHYLAXIS PASTEK012889BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANTK030488FLUORILAQK912632OCCLUDE

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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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