Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIGHT GUARD

K-Number: K061122 · 2007-03-12

ApplicantAlpine Oral Care, LLC
Decision Date2007-03-12
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

NIGHT GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Alpine Oral Care, LLC. It received FDA 510(k) clearance on 2007-03-12 under 510(k) number K061122. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIGHT GUARD?

NIGHT GUARD is a medical device that received FDA 510(k) clearance on 2007-03-12. The listed applicant is Alpine Oral Care, LLC. The 510(k) number is K061122.

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

NIGHT GUARD received FDA 510(k) clearance on 2007-03-12, under 510(k) number K061122.

Who is the listed applicant for NIGHT GUARD?

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

What is the FDA product code for NIGHT GUARD?

The FDA product code for NIGHT GUARD is MQC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑