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FDA 510(k)

GRIND GUARD

K-Number: K090472 · 2009-10-14

ApplicantArchtek, Inc.
Decision Date2009-10-14
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

GRIND GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Archtek, Inc.. It received FDA 510(k) clearance on 2009-10-14 under 510(k) number K090472. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRIND GUARD?

GRIND GUARD is a medical device that received FDA 510(k) clearance on 2009-10-14. The listed applicant is Archtek, Inc.. The 510(k) number is K090472.

When did GRIND GUARD receive FDA 510(k) clearance?

GRIND GUARD received FDA 510(k) clearance on 2009-10-14, under 510(k) number K090472.

Who is the listed applicant for GRIND GUARD?

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

What is the FDA product code for GRIND GUARD?

The FDA product code for GRIND GUARD is MQC.

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Other records listing Archtek, 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.

K073446GRIND GUARD

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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