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)

IVOBASE HYBRID, IVOBASE HIGH IMPACT

K-Number: K103391 · 2011-02-17

ApplicantIvoclar Vivadent, Inc.
Decision Date2011-02-17
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IVOBASE HYBRID, IVOBASE HIGH IMPACT is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2011-02-17 under 510(k) number K103391. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVOBASE HYBRID, IVOBASE HIGH IMPACT?

IVOBASE HYBRID, IVOBASE HIGH IMPACT is a medical device that received FDA 510(k) clearance on 2011-02-17. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K103391.

When did IVOBASE HYBRID, IVOBASE HIGH IMPACT receive FDA 510(k) clearance?

IVOBASE HYBRID, IVOBASE HIGH IMPACT received FDA 510(k) clearance on 2011-02-17, under 510(k) number K103391.

Who is the listed applicant for IVOBASE HYBRID, IVOBASE HIGH IMPACT?

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

What is the FDA product code for IVOBASE HYBRID, IVOBASE HIGH IMPACT?

The FDA product code for IVOBASE HYBRID, IVOBASE HIGH IMPACT is EBI.

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 Ivoclar Vivadent, 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.

K261485Tetric plus Fill;Tetric plus FlowK253953IPS e.max ZirconiaK252450Adhese 2K233995Ivotion Base PrintK153753TelioCAD MultiK111958TETRIC EVOCERAM BULK FILL

View all 64 devices →

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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.

↑