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)

PREMIER IMPLANT CEMENT, MODEL 3001450

K-Number: K033309 · 2004-01-26

ApplicantPremier Dental Products Co.
Decision Date2004-01-26
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIER IMPLANT CEMENT, MODEL 3001450 is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 2004-01-26 under 510(k) number K033309. 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 PREMIER IMPLANT CEMENT, MODEL 3001450?

PREMIER IMPLANT CEMENT, MODEL 3001450 is a medical device that received FDA 510(k) clearance on 2004-01-26. The listed applicant is Premier Dental Products Co.. The 510(k) number is K033309.

When did PREMIER IMPLANT CEMENT, MODEL 3001450 receive FDA 510(k) clearance?

PREMIER IMPLANT CEMENT, MODEL 3001450 received FDA 510(k) clearance on 2004-01-26, under 510(k) number K033309.

Who is the listed applicant for PREMIER IMPLANT CEMENT, MODEL 3001450?

The FDA 510(k) record lists Premier Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMIER IMPLANT CEMENT, MODEL 3001450?

The FDA product code for PREMIER IMPLANT CEMENT, MODEL 3001450 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 Premier Dental Products Co. 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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK083695TRAXODENTK062166ENAMEL PROK062683ENAMEL PRO VARNISHK061997PREMIER SELF-ETCHING ENAMEL SEALANT

View all 40 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.

↑