FDA 510(k)

KNIT-PAK+

K-Number: K132526 · 2013-11-26

Decision Date2013-11-26

Product CodeMVL

DecisionSubstantially Equivalent

Device Summary

KNIT-PAK+ is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 2013-11-26 under 510(k) number K132526. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KNIT-PAK+?

KNIT-PAK+ is a medical device that received FDA 510(k) clearance on 2013-11-26. The listed applicant is Premier Dental Products Co.. The 510(k) number is K132526.

When did KNIT-PAK+ receive FDA 510(k) clearance?

KNIT-PAK+ received FDA 510(k) clearance on 2013-11-26, under 510(k) number K132526.

Who is the listed applicant for KNIT-PAK+?

The FDA 510(k) record lists Premier Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KNIT-PAK+?

The FDA product code for KNIT-PAK+ is MVL.

Other records listing Premier Dental Products Co. 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.

K131212PREMIER CERAMIC PRIMER K083695TRAXODENT K062166ENAMEL PRO K062683ENAMEL PRO VARNISH K061998PREMIER SELF-ETCHING BOND ENHANCER K061997PREMIER SELF-ETCHING ENAMEL SEALANT

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Related Devices (Code: MVL)

K254239CyClean CordSS GLOBAL K253797One-StopMediclus Co., Ltd.K243910RetraxilKulzer, LLC K211420Stasis GelBelport Company, Inc., Gingi-Pak K211419Gingi-Aid GelBelport Company, Inc., Gingi-Pak K213149VOCO 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.