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)

ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)

K-Number: K982201 · 1998-08-10

ApplicantForemost Dental Mfg., Inc.
Decision Date1998-08-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) is the device name listed in this FDA 510(k) record. The listed applicant is Foremost Dental Mfg., Inc.. It received FDA 510(k) clearance on 1998-08-10 under 510(k) number K982201. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)?

ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) is a medical device that received FDA 510(k) clearance on 1998-08-10. The listed applicant is Foremost Dental Mfg., Inc.. The 510(k) number is K982201.

When did ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) receive FDA 510(k) clearance?

ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) received FDA 510(k) clearance on 1998-08-10, under 510(k) number K982201.

Who is the listed applicant for ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)?

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

What is the FDA product code for ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)?

The FDA product code for ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) is EBF.

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 Foremost Dental Mfg., 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.

K981813PERMACEM AUTOMIX LUTING CEMENT SYSTEMK980963HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)K970683ZENTIH FLOWABLE COMPOSITE (MULTIPLE)K970774TEMPOCEM NE (MULTIPLE)K970775TEMPO CEM (MULTIPLE)K954867IONOSIT SEAL

View all 14 devices →

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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.

↑