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FDA 510(k)

BRITESMILE MASKING CREAM

K-Number: K040797 · 2004-04-02

ApplicantBritesmile, Inc.
Decision Date2004-04-02
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRITESMILE MASKING CREAM is the device name listed in this FDA 510(k) record. The listed applicant is Britesmile, Inc.. It received FDA 510(k) clearance on 2004-04-02 under 510(k) number K040797. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRITESMILE MASKING CREAM?

BRITESMILE MASKING CREAM is a medical device that received FDA 510(k) clearance on 2004-04-02. The listed applicant is Britesmile, Inc.. The 510(k) number is K040797.

When did BRITESMILE MASKING CREAM receive FDA 510(k) clearance?

BRITESMILE MASKING CREAM received FDA 510(k) clearance on 2004-04-02, under 510(k) number K040797.

Who is the listed applicant for BRITESMILE MASKING CREAM?

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

What is the FDA product code for BRITESMILE MASKING CREAM?

The FDA product code for BRITESMILE MASKING CREAM is EIE.

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 Britesmile, 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.

K010935BRITESMILE BARRIER MATERIAL

Related Devices (Code: EIE)

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.

K182118armor LCMavrik Dental Systems, Ltd.K151945Triumph Resin DamDenali CorporationK050318BARI-KAD PACKING DEVICEBioenvelop Agro, Inc.K043301GC TION GINGIVAL PROTECTORGC America, Inc.K022522PULPDENT PUTTY DAMPulpdent CorporationK021524LIGHT CURE DENTAL DAMPrime Dental Manufacturing, 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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