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)

CEMENT-IT ALL PURPOSE, MODEL N97

K-Number: K060698 · 2006-05-10

ApplicantPentron Clinical Technologies
Decision Date2006-05-10
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEMENT-IT ALL PURPOSE, MODEL N97 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 2006-05-10 under 510(k) number K060698. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEMENT-IT ALL PURPOSE, MODEL N97?

CEMENT-IT ALL PURPOSE, MODEL N97 is a medical device that received FDA 510(k) clearance on 2006-05-10. The listed applicant is Pentron Clinical Technologies. The 510(k) number is K060698.

When did CEMENT-IT ALL PURPOSE, MODEL N97 receive FDA 510(k) clearance?

CEMENT-IT ALL PURPOSE, MODEL N97 received FDA 510(k) clearance on 2006-05-10, under 510(k) number K060698.

Who is the listed applicant for CEMENT-IT ALL PURPOSE, MODEL N97?

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 CEMENT-IT ALL PURPOSE, MODEL N97?

The FDA product code for CEMENT-IT ALL PURPOSE, MODEL N97 is EMA.

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 ADHESIVEK072545ARTISTE SE FLOWABLE COMPOSITE, MODEL N280K071500NANO-BOND II ADHESIVE SYSTEM

View all 13 devices →

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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.

↑