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FDA 510(k)

DEFLEX

K-Number: K113608 · 2012-04-10

ApplicantNuxen S.R.L.
Decision Date2012-04-10
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Nuxen S.R.L.. It received FDA 510(k) clearance on 2012-04-10 under 510(k) number K113608. 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 DEFLEX?

DEFLEX is a medical device that received FDA 510(k) clearance on 2012-04-10. The listed applicant is Nuxen S.R.L.. The 510(k) number is K113608.

When did DEFLEX receive FDA 510(k) clearance?

DEFLEX received FDA 510(k) clearance on 2012-04-10, under 510(k) number K113608.

Who is the listed applicant for DEFLEX?

The FDA 510(k) record lists Nuxen S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFLEX?

The FDA product code for DEFLEX 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 Nuxen S.R.L. 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.

K113788DEFLEX ACRILATO

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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