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FDA 510(k)

PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE

K-Number: K100539 · 2010-06-17

ApplicantPreventive Technologies, Inc.
Decision Date2010-06-17
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Preventive Technologies, Inc.. It received FDA 510(k) clearance on 2010-06-17 under 510(k) number K100539. 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 PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE?

PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE is a medical device that received FDA 510(k) clearance on 2010-06-17. The listed applicant is Preventive Technologies, Inc.. The 510(k) number is K100539.

When did PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE receive FDA 510(k) clearance?

PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE received FDA 510(k) clearance on 2010-06-17, under 510(k) number K100539.

Who is the listed applicant for PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE?

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

What is the FDA product code for PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE?

The FDA product code for PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE 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 Preventive Technologies, 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.

K951016DISPOSABLE PROPHYLAXIS ANGLE

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 GmbHK070854GC MI PASTE PLUSGC America, 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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