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FDA 510(k)

BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN

K-Number: K041371 · 2004-08-23

ApplicantNovamin Technology, Inc.
Decision Date2004-08-23
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN is the device name listed in this FDA 510(k) record. The listed applicant is Novamin Technology, Inc.. It received FDA 510(k) clearance on 2004-08-23 under 510(k) number K041371. 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 BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN?

BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN is a medical device that received FDA 510(k) clearance on 2004-08-23. The listed applicant is Novamin Technology, Inc.. The 510(k) number is K041371.

When did BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN receive FDA 510(k) clearance?

BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN received FDA 510(k) clearance on 2004-08-23, under 510(k) number K041371.

Who is the listed applicant for BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN?

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

What is the FDA product code for BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN?

The FDA product code for BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN is EJR.

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Other records listing Novamin Technology, 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.

K080228ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETHK071267PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMINK061359DENSHIELD TREATMENT FOR SENSITIVE TEETHK040858ORALIEF THERAPY FOR SENSITIVE TEETHK040473ORAVIVE TOOTH REVITALIZING PASTEK033295BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN

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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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