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)

PrimmaArt

K-Number: K231859 · 2024-11-26

ApplicantDentscare Ltda
Decision Date2024-11-26
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PrimmaArt is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K231859. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PrimmaArt?

PrimmaArt is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Dentscare Ltda. The 510(k) number is K231859.

When did PrimmaArt receive FDA 510(k) clearance?

PrimmaArt received FDA 510(k) clearance on 2024-11-26, under 510(k) number K231859.

Who is the listed applicant for PrimmaArt?

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

What is the FDA product code for PrimmaArt?

The FDA product code for PrimmaArt is EBG.

Other records listing Dentscare Ltda 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.

K232994Vittra APS Unique FlowK210231Vittra APS UniqueK201707Opallis, Opallis FlowK192682Orthocem, Ortho BiteK191389Allcem Veneer APSK191306Llis, Vittra APS

View all 10 devices →

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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.

↑