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)

ARTISTE SE FLOWABLE COMPOSITE, MODEL N280

K-Number: K072545 · 2007-10-26

ApplicantPentron Clinical Technologies
Decision Date2007-10-26
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Clinical Technologies. It received FDA 510(k) clearance on 2007-10-26 under 510(k) number K072545. 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 ARTISTE SE FLOWABLE COMPOSITE, MODEL N280?

ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 is a medical device that received FDA 510(k) clearance on 2007-10-26. The listed applicant is Pentron Clinical Technologies. The 510(k) number is K072545.

When did ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 receive FDA 510(k) clearance?

ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 received FDA 510(k) clearance on 2007-10-26, under 510(k) number K072545.

Who is the listed applicant for ARTISTE SE FLOWABLE COMPOSITE, MODEL N280?

The FDA 510(k) record lists Pentron Clinical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTISTE SE FLOWABLE COMPOSITE, MODEL N280?

The FDA product code for ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 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 Pentron Clinical Technologies 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.

K091512BUILD-IT LIGHT CUREK081887LUTE-IT II VENEER CEMENT, MODEL NO6K072830RM BOND, MODEL J032K072480GENERATION 8 SE ADHESIVEK071500NANO-BOND II ADHESIVE SYSTEMK060889SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE

View all 13 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.

↑