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)

POLYCARBOXYLATE (PCA) CEMENT

K-Number: K010240 · 2001-03-27

ApplicantRite-Dent Manufacturing Corp.
Decision Date2001-03-27
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYCARBOXYLATE (PCA) CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Rite-Dent Manufacturing Corp.. It received FDA 510(k) clearance on 2001-03-27 under 510(k) number K010240. 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 POLYCARBOXYLATE (PCA) CEMENT?

POLYCARBOXYLATE (PCA) CEMENT is a medical device that received FDA 510(k) clearance on 2001-03-27. The listed applicant is Rite-Dent Manufacturing Corp.. The 510(k) number is K010240.

When did POLYCARBOXYLATE (PCA) CEMENT receive FDA 510(k) clearance?

POLYCARBOXYLATE (PCA) CEMENT received FDA 510(k) clearance on 2001-03-27, under 510(k) number K010240.

Who is the listed applicant for POLYCARBOXYLATE (PCA) CEMENT?

The FDA 510(k) record lists Rite-Dent Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYCARBOXYLATE (PCA) CEMENT?

The FDA product code for POLYCARBOXYLATE (PCA) CEMENT 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 Rite-Dent Manufacturing Corp. 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.

K020050ENAMEL BONDING SYSTEMK011822PIT AND FISSURE CHEMICAL CURING SEALANTK011453TOOTH SHADE RESIN MATERIALK010255CAVITY VARNISHK003427ZINC PHOSPHATE CEMENTK003426ALGINATE IMPRESSION MATERIAL

View all 7 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.

↑