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FDA 510(k)

SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE

K-Number: K123161 · 2013-03-14

ApplicantSmartguard, Inc.
Decision Date2013-03-14
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Smartguard, Inc.. It received FDA 510(k) clearance on 2013-03-14 under 510(k) number K123161. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE?

SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Smartguard, Inc.. The 510(k) number is K123161.

When did SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE receive FDA 510(k) clearance?

SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE received FDA 510(k) clearance on 2013-03-14, under 510(k) number K123161.

Who is the listed applicant for SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE?

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

What is the FDA product code for SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE?

The FDA product code for SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE is MQC.

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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

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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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