PrimmaArt

FDA UDI

Class II (US FDA UDI)

by Dentscare Ltda

Identity

Trade Name: PrimmaArt FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles. FDA UDI
Model / Reference: CART 75G 20UN FDA UDI
Description: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles. FDA UDI

Identifiers

Catalog Number: 4000056648 FDA UDI
Primary DI / UDI-DI: 07899633835461 FDA UDI
510(k) Number: K231859 FDA UDI
FDA Product Code: EBG FDA UDI
POW FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental composite resin

PrimmaArt by Dentscare Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K231859 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dentscare Ltda

Sources (1)

FDA UDI e5bdf4b4-a708-4086-9891-cc6d41d119b5 35 fields · synced May 30, 2026