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FDA 510(k)

PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES

K-Number: K033449 · 2004-01-07

ApplicantProfessional Dental Technologies Therapeutics, Inc.
Decision Date2004-01-07
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Professional Dental Technologies Therapeutics, Inc.. It received FDA 510(k) clearance on 2004-01-07 under 510(k) number K033449. 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 PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES?

PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES is a medical device that received FDA 510(k) clearance on 2004-01-07. The listed applicant is Professional Dental Technologies Therapeutics, Inc.. The 510(k) number is K033449.

When did PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES receive FDA 510(k) clearance?

PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES received FDA 510(k) clearance on 2004-01-07, under 510(k) number K033449.

Who is the listed applicant for PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES?

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

What is the FDA product code for PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES?

The FDA product code for PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES is EJR.

Related Clinical Trials

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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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