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)

ESTENIA C&B

K-Number: K042929 · 2004-12-06

ApplicantKuraray Medical Kurashiki Plant
Decision Date2004-12-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESTENIA C&B is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical Kurashiki Plant. It received FDA 510(k) clearance on 2004-12-06 under 510(k) number K042929. 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 ESTENIA C&B?

ESTENIA C&B is a medical device that received FDA 510(k) clearance on 2004-12-06. The listed applicant is Kuraray Medical Kurashiki Plant. The 510(k) number is K042929.

When did ESTENIA C&B receive FDA 510(k) clearance?

ESTENIA C&B received FDA 510(k) clearance on 2004-12-06, under 510(k) number K042929.

Who is the listed applicant for ESTENIA C&B?

The FDA 510(k) record lists Kuraray Medical Kurashiki Plant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTENIA C&B?

The FDA product code for ESTENIA C&B 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 Kuraray Medical Kurashiki Plant 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.

K051796CLEARFIL TRI-S BOND SINGLE DOSE

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.

↑