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FDA 510(k)

TRAXODENT

K-Number: K083695 · 2009-04-28

ApplicantPremier Dental Products Co.
Decision Date2009-04-28
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

TRAXODENT 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 2009-04-28 under 510(k) number K083695. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAXODENT?

TRAXODENT is a medical device that received FDA 510(k) clearance on 2009-04-28. The listed applicant is Premier Dental Products Co.. The 510(k) number is K083695.

When did TRAXODENT receive FDA 510(k) clearance?

TRAXODENT received FDA 510(k) clearance on 2009-04-28, under 510(k) number K083695.

Who is the listed applicant for TRAXODENT?

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 TRAXODENT?

The FDA product code for TRAXODENT is MVL.

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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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK062166ENAMEL PROK062683ENAMEL PRO VARNISHK061998PREMIER SELF-ETCHING BOND ENHANCERK061997PREMIER SELF-ETCHING ENAMEL SEALANT

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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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