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)

LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS

K-Number: K960600 · 1996-04-26

ApplicantDent Zar, Inc.
Decision Date1996-04-26
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS is the device name listed in this FDA 510(k) record. The listed applicant is Dent Zar, Inc.. It received FDA 510(k) clearance on 1996-04-26 under 510(k) number K960600. 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 LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS?

LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS is a medical device that received FDA 510(k) clearance on 1996-04-26. The listed applicant is Dent Zar, Inc.. The 510(k) number is K960600.

When did LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS receive FDA 510(k) clearance?

LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS received FDA 510(k) clearance on 1996-04-26, under 510(k) number K960600.

Who is the listed applicant for LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS?

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

What is the FDA product code for LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS?

The FDA product code for LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS 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 Dent Zar, 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.

K962277SELF CURE BONDING AGENTK960594LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETSK960595FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETSK960597ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CUREK960598CONCORD MARYLAND BRIDGE CEMENTK960599SUPERIOR PHOTOCURING HYBRID COMPOSITE

View all 12 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.

↑