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FDA 510(k)

KORLEX-GR GINGIVAL RETRACTION PASTE

K-Number: K053329 · 2006-02-15

ApplicantBiotech One, Inc.
Decision Date2006-02-15
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

KORLEX-GR GINGIVAL RETRACTION PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Biotech One, Inc.. It received FDA 510(k) clearance on 2006-02-15 under 510(k) number K053329. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KORLEX-GR GINGIVAL RETRACTION PASTE?

KORLEX-GR GINGIVAL RETRACTION PASTE is a medical device that received FDA 510(k) clearance on 2006-02-15. The listed applicant is Biotech One, Inc.. The 510(k) number is K053329.

When did KORLEX-GR GINGIVAL RETRACTION PASTE receive FDA 510(k) clearance?

KORLEX-GR GINGIVAL RETRACTION PASTE received FDA 510(k) clearance on 2006-02-15, under 510(k) number K053329.

Who is the listed applicant for KORLEX-GR GINGIVAL RETRACTION PASTE?

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

What is the FDA product code for KORLEX-GR GINGIVAL RETRACTION PASTE?

The FDA product code for KORLEX-GR GINGIVAL RETRACTION PASTE 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 Biotech One, 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.

K040650BONAMATES SERIES

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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