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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 a medical device manufactured by Dentscare Ltda. It received FDA 510(k) clearance on 2024-11-26 under approval 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. It is manufactured by Dentscare Ltda. The 510(k) number is K231859.

When was PrimmaArt approved by the FDA?

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

What company makes PrimmaArt?

PrimmaArt is manufactured by Dentscare Ltda.

What is the FDA product code for PrimmaArt?

The FDA product code for PrimmaArt is EBG.

Other Devices by Dentscare Ltda

K191306Llis, Vittra APS K183424Ambar, Ambar APS, Ambar Universal APS K183465Allcem, Allcem Core K190758Opus Bulk Fill APS, Opus Bulk Fill Flow APS K201707Opallis, Opallis Flow K192682Orthocem, Ortho Bite

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Related Devices (Code: EBG)

K153490DD medical polymersDental Direkt GmbH K152443Vericore Gradient Temporary DiscWhip Mix Corporation K153753TelioCAD MultiIvoclar Vivadent, Inc. K152215DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLORDentalplus GmbH K171729Fixtemp C&BDreve Dentamid GmbH K172281PuRE PMMA DiscQuest Dental USA Corp.

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.

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