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FDA 510(k)

BRITESMILE BARRIER MATERIAL

K-Number: K010935 · 2001-09-05

ApplicantBritesmile, Inc.
Decision Date2001-09-05
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRITESMILE BARRIER MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Britesmile, Inc.. It received FDA 510(k) clearance on 2001-09-05 under 510(k) number K010935. 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 BARRIER MATERIAL?

BRITESMILE BARRIER MATERIAL is a medical device that received FDA 510(k) clearance on 2001-09-05. The listed applicant is Britesmile, Inc.. The 510(k) number is K010935.

When did BRITESMILE BARRIER MATERIAL receive FDA 510(k) clearance?

BRITESMILE BARRIER MATERIAL received FDA 510(k) clearance on 2001-09-05, under 510(k) number K010935.

Who is the listed applicant for BRITESMILE BARRIER MATERIAL?

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 BARRIER MATERIAL?

The FDA product code for BRITESMILE BARRIER MATERIAL is EIE.

Related Clinical Trials

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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.

K040797BRITESMILE MASKING CREAM

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.K040797BRITESMILE MASKING CREAMBritesmile, Inc.K022522PULPDENT PUTTY DAMPulpdent Corporation

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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