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FDA 510(k)

DOCTOR'S NIGHTGUARD

K-Number: K053580 · 2006-03-03

ApplicantDental Concepts, LLC
Decision Date2006-03-03
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

DOCTOR'S NIGHTGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Dental Concepts, LLC. It received FDA 510(k) clearance on 2006-03-03 under 510(k) number K053580. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCTOR'S NIGHTGUARD?

DOCTOR'S NIGHTGUARD is a medical device that received FDA 510(k) clearance on 2006-03-03. The listed applicant is Dental Concepts, LLC. The 510(k) number is K053580.

When did DOCTOR'S NIGHTGUARD receive FDA 510(k) clearance?

DOCTOR'S NIGHTGUARD received FDA 510(k) clearance on 2006-03-03, under 510(k) number K053580.

Who is the listed applicant for DOCTOR'S NIGHTGUARD?

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

What is the FDA product code for DOCTOR'S NIGHTGUARD?

The FDA product code for DOCTOR'S NIGHTGUARD is MQC.

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Other records listing Dental Concepts, LLC 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.

K024261DENTAL PROTECTORK844238ORAPIK PERIODONTAL SCALER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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