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)

FRC POSTEC PLUS

K-Number: K042848 · 2004-11-22

ApplicantIvoclar Vivadent, Inc.
Decision Date2004-11-22
Product CodeELR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FRC POSTEC PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2004-11-22 under 510(k) number K042848. The device is classified under product code ELR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRC POSTEC PLUS?

FRC POSTEC PLUS is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K042848.

When did FRC POSTEC PLUS receive FDA 510(k) clearance?

FRC POSTEC PLUS received FDA 510(k) clearance on 2004-11-22, under 510(k) number K042848.

Who is the listed applicant for FRC POSTEC PLUS?

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

What is the FDA product code for FRC POSTEC PLUS?

The FDA product code for FRC POSTEC PLUS is ELR.

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 Ivoclar Vivadent, Inc. 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.

K261485Tetric plus Fill;Tetric plus FlowK253953IPS e.max ZirconiaK252450Adhese 2K233995Ivotion Base PrintK153753TelioCAD MultiK111958TETRIC EVOCERAM BULK FILL

View all 64 devices →

Related Devices (Code: ELR)

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.

K060075FIBER-METAL POSTForemost Dental, LLCK030820EVERSTICK POSTStick Tech , Ltd.K020431FIBIOCOREEst. AnthogyrK012496CARBON POSTJ. Morita USA, Inc.K013802FRC POSTECIvoclar Vivadent, Inc.K012849GLASS POSTJ. Morita USA, 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.

↑