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)

POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)

K-Number: K954976 · 1996-04-25

ApplicantHealex Products, Inc.
Decision Date1996-04-25
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Healex Products, Inc.. It received FDA 510(k) clearance on 1996-04-25 under 510(k) number K954976. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)?

POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-04-25. The listed applicant is Healex Products, Inc.. The 510(k) number is K954976.

When did POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) receive FDA 510(k) clearance?

POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) received FDA 510(k) clearance on 1996-04-25, under 510(k) number K954976.

Who is the listed applicant for POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)?

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

What is the FDA product code for POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)?

The FDA product code for POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) is EBG.

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 Healex Products, 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.

K030727POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENTK961457SUBLIMINATOR

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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.

↑