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FDA 510(k)

ENAMELITE ACRYSEAL SPRAY SEALANT

K-Number: K093019 · 2009-12-22

ApplicantEnamelite, LLC
Decision Date2009-12-22
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENAMELITE ACRYSEAL SPRAY SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Enamelite, LLC. It received FDA 510(k) clearance on 2009-12-22 under 510(k) number K093019. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENAMELITE ACRYSEAL SPRAY SEALANT?

ENAMELITE ACRYSEAL SPRAY SEALANT is a medical device that received FDA 510(k) clearance on 2009-12-22. The listed applicant is Enamelite, LLC. The 510(k) number is K093019.

When did ENAMELITE ACRYSEAL SPRAY SEALANT receive FDA 510(k) clearance?

ENAMELITE ACRYSEAL SPRAY SEALANT received FDA 510(k) clearance on 2009-12-22, under 510(k) number K093019.

Who is the listed applicant for ENAMELITE ACRYSEAL SPRAY SEALANT?

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

What is the FDA product code for ENAMELITE ACRYSEAL SPRAY SEALANT?

The FDA product code for ENAMELITE ACRYSEAL SPRAY SEALANT is EBD.

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Other records listing Enamelite, LLC as applicant

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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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