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FDA 510(k)

ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH

K-Number: K080228 · 2008-03-27

ApplicantNovamin Technology, Inc.
Decision Date2008-03-27
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH 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 2008-03-27 under 510(k) number K080228. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH?

ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH is a medical device that received FDA 510(k) clearance on 2008-03-27. The listed applicant is Novamin Technology, Inc.. The 510(k) number is K080228.

When did ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH receive FDA 510(k) clearance?

ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH received FDA 510(k) clearance on 2008-03-27, under 510(k) number K080228.

Who is the listed applicant for ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH?

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 ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH?

The FDA product code for ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH is LBH.

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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.

K071267PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMINK061359DENSHIELD TREATMENT FOR SENSITIVE TEETHK040858ORALIEF THERAPY FOR SENSITIVE TEETHK041371BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMINK040473ORAVIVE TOOTH REVITALIZING PASTEK033295BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN

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Related Devices (Code: LBH)

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.

K262243Profisil FreeKettenbach GmbH & Co. KGK253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, 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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