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FDA 510(k)

RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE

K-Number: K113839 · 2012-04-12

ApplicantParkell, Inc.
Decision Date2012-04-12
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2012-04-12 under 510(k) number K113839. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE?

RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE is a medical device that received FDA 510(k) clearance on 2012-04-12. The listed applicant is Parkell, Inc.. The 510(k) number is K113839.

When did RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE receive FDA 510(k) clearance?

RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE received FDA 510(k) clearance on 2012-04-12, under 510(k) number K113839.

Who is the listed applicant for RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE?

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

What is the FDA product code for RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE?

The FDA product code for RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE is MVL.

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Other records listing Parkell, Inc. as applicant

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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

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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