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FDA 510(k)

SULCUS BLUE

K-Number: K111978 · 2011-10-13

ApplicantProduits Dentaires Pierre Rolland
Decision Date2011-10-13
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

SULCUS BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Produits Dentaires Pierre Rolland. It received FDA 510(k) clearance on 2011-10-13 under 510(k) number K111978. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SULCUS BLUE?

SULCUS BLUE is a medical device that received FDA 510(k) clearance on 2011-10-13. The listed applicant is Produits Dentaires Pierre Rolland. The 510(k) number is K111978.

When did SULCUS BLUE receive FDA 510(k) clearance?

SULCUS BLUE received FDA 510(k) clearance on 2011-10-13, under 510(k) number K111978.

Who is the listed applicant for SULCUS BLUE?

The FDA 510(k) record lists Produits Dentaires Pierre Rolland as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SULCUS BLUE?

The FDA product code for SULCUS BLUE is MVL.

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 Produits Dentaires Pierre Rolland 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.

K050180EXPA-SYL

Related Devices (Code: MVL)

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.

K254239CyClean CordSS GLOBALK253797One-StopMediclus Co., Ltd.K243910RetraxilKulzer, LLCK211420Stasis GelBelport Company, Inc., Gingi-PakK211419Gingi-Aid GelBelport Company, Inc., Gingi-PakK213149VOCO Retraction PasteVoco GmbH

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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