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FDA 510(k)

ENAMELAST

K-Number: K132109 · 2013-11-01

ApplicantUltradent Products Inc. / Oratech, LLC
Decision Date2013-11-01
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENAMELAST is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products Inc. / Oratech, LLC. It received FDA 510(k) clearance on 2013-11-01 under 510(k) number K132109. 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 ENAMELAST?

ENAMELAST is a medical device that received FDA 510(k) clearance on 2013-11-01. The listed applicant is Ultradent Products Inc. / Oratech, LLC. The 510(k) number is K132109.

When did ENAMELAST receive FDA 510(k) clearance?

ENAMELAST received FDA 510(k) clearance on 2013-11-01, under 510(k) number K132109.

Who is the listed applicant for ENAMELAST?

The FDA 510(k) record lists Ultradent Products Inc. / Oratech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENAMELAST?

The FDA product code for ENAMELAST 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 Ultradent Products Inc. / Oratech, LLC 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.

K132255ULTRACEM

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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