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)

PROFIL COMPOSITES (PROFIL, PROFIL FLOW)

K-Number: K103190 · 2011-02-02

ApplicantSilmet , Ltd.
Decision Date2011-02-02
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROFIL COMPOSITES (PROFIL, PROFIL FLOW) is the device name listed in this FDA 510(k) record. The listed applicant is Silmet , Ltd.. It received FDA 510(k) clearance on 2011-02-02 under 510(k) number K103190. 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 PROFIL COMPOSITES (PROFIL, PROFIL FLOW)?

PROFIL COMPOSITES (PROFIL, PROFIL FLOW) is a medical device that received FDA 510(k) clearance on 2011-02-02. The listed applicant is Silmet , Ltd.. The 510(k) number is K103190.

When did PROFIL COMPOSITES (PROFIL, PROFIL FLOW) receive FDA 510(k) clearance?

PROFIL COMPOSITES (PROFIL, PROFIL FLOW) received FDA 510(k) clearance on 2011-02-02, under 510(k) number K103190.

Who is the listed applicant for PROFIL COMPOSITES (PROFIL, PROFIL FLOW)?

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

What is the FDA product code for PROFIL COMPOSITES (PROFIL, PROFIL FLOW)?

The FDA product code for PROFIL COMPOSITES (PROFIL, PROFIL FLOW) 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 Silmet , Ltd. 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.

K110403PROLINK ADHESIVES (PROLINK, PROLINK SE)K101869PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)

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.

↑