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FDA 510(k)

DEN TEK NIGHTGUARD

K-Number: K063483 · 2007-01-23

ApplicantDen Tek Oral Care, Inc.
Decision Date2007-01-23
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

DEN TEK NIGHTGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Den Tek Oral Care, Inc.. It received FDA 510(k) clearance on 2007-01-23 under 510(k) number K063483. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEN TEK NIGHTGUARD?

DEN TEK NIGHTGUARD is a medical device that received FDA 510(k) clearance on 2007-01-23. The listed applicant is Den Tek Oral Care, Inc.. The 510(k) number is K063483.

When did DEN TEK NIGHTGUARD receive FDA 510(k) clearance?

DEN TEK NIGHTGUARD received FDA 510(k) clearance on 2007-01-23, under 510(k) number K063483.

Who is the listed applicant for DEN TEK NIGHTGUARD?

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

What is the FDA product code for DEN TEK NIGHTGUARD?

The FDA product code for DEN TEK NIGHTGUARD is MQC.

Related Clinical Trials

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Other records listing Den Tek Oral Care, 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.

K130186DENTEK EASY BRUSH WITH FLUORIDEK123849NEW COMFORT-FIT DENTAL GUARDK091660CUSTOM COMFORT NIGHTGUARD VERSION 2K083400CUSTOM COMFORT NIGHTGUARDK081669IMPROVED COMFORT-FIT NIGHTGUARDK072147DEN TEK COMFORT FIT NIGHTGUARD

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Related Devices (Code: MQC)

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.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material CorporationK241729Hard Splint & Thermo-Adaptive SplintWhip Mix CorporationK243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

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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