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FDA 510(k)

DURAFLOR

K-Number: K961893 · 1996-08-14

ApplicantPharmascience, Inc.
Decision Date1996-08-14
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DURAFLOR is the device name listed in this FDA 510(k) record. The listed applicant is Pharmascience, Inc.. It received FDA 510(k) clearance on 1996-08-14 under 510(k) number K961893. 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 DURAFLOR?

DURAFLOR is a medical device that received FDA 510(k) clearance on 1996-08-14. The listed applicant is Pharmascience, Inc.. The 510(k) number is K961893.

When did DURAFLOR receive FDA 510(k) clearance?

DURAFLOR received FDA 510(k) clearance on 1996-08-14, under 510(k) number K961893.

Who is the listed applicant for DURAFLOR?

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

What is the FDA product code for DURAFLOR?

The FDA product code for DURAFLOR is LBH.

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 Pharmascience, 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.

K931096DURAFLOR

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

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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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