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)

NIGHTGUARD DIAGNOSTIC APPLIANCE

K-Number: K955701 · 1996-03-08

ApplicantCycura Corp.
Decision Date1996-03-08
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

NIGHTGUARD DIAGNOSTIC APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Cycura Corp.. It received FDA 510(k) clearance on 1996-03-08 under 510(k) number K955701. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIGHTGUARD DIAGNOSTIC APPLIANCE?

NIGHTGUARD DIAGNOSTIC APPLIANCE is a medical device that received FDA 510(k) clearance on 1996-03-08. The listed applicant is Cycura Corp.. The 510(k) number is K955701.

When did NIGHTGUARD DIAGNOSTIC APPLIANCE receive FDA 510(k) clearance?

NIGHTGUARD DIAGNOSTIC APPLIANCE received FDA 510(k) clearance on 1996-03-08, under 510(k) number K955701.

Who is the listed applicant for NIGHTGUARD DIAGNOSTIC APPLIANCE?

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

What is the FDA product code for NIGHTGUARD DIAGNOSTIC APPLIANCE?

The FDA product code for NIGHTGUARD DIAGNOSTIC APPLIANCE 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

Other records listing Cycura Corp. 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.

K953257ORALSENSOR

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.

↑