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)

AURAVENEER CEMENT

K-Number: K073101 · 2008-01-17

ApplicantDenali Corporation
Decision Date2008-01-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURAVENEER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Denali Corporation. It received FDA 510(k) clearance on 2008-01-17 under 510(k) number K073101. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAVENEER CEMENT?

AURAVENEER CEMENT is a medical device that received FDA 510(k) clearance on 2008-01-17. The listed applicant is Denali Corporation. The 510(k) number is K073101.

When did AURAVENEER CEMENT receive FDA 510(k) clearance?

AURAVENEER CEMENT received FDA 510(k) clearance on 2008-01-17, under 510(k) number K073101.

Who is the listed applicant for AURAVENEER CEMENT?

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

What is the FDA product code for AURAVENEER CEMENT?

The FDA product code for AURAVENEER CEMENT is EMA.

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 Denali Corporation 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.

K153191Calcium BridgeK151945Triumph Resin DamK071158AURALAY PIT & FISSURE SEALANTK070702FUSION RESIN CEMENT AND CORE KITK070693AURAVUE PIT & FISSURE SEALANT

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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.

↑