PriZma 3D Bio Crown Diamond - DA2 (300 g)

FDA UDI

Class II (US FDA UDI)

by Maquira Industria de Produtos Odontologicos S/A

Identity

Trade Name: PriZma 3D Bio Crown Diamond - DA2 (300 g) FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: PRIZMA 3D BIO CROWN DIAMOND is a nanohybrid resin for preparation of dental crowns. FDA UDI
Model / Reference: PriZma 3D Bio Crown Diamond FDA UDI
Description: PRIZMA 3D BIO CROWN DIAMOND is a nanohybrid resin for preparation of dental crowns. FDA UDI

Identifiers

Catalog Number: 80483749007 FDA UDI
Primary DI / UDI-DI: 07898561549327 FDA UDI
FDA Product Code: ELM FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3590 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental appliance fabrication material, resin

PriZma 3D Bio Crown Diamond - DA2 (300 g) by Maquira Industria de Produtos Odontologicos S/A — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Dental appliance fabrication material, resin.

O-Cryl Self Curing Acrylic Shade White X 1 lb — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
PREMIUM — Lang Dental Manufacturing Company, Inc. · Class II
Axcent Acrylics — GARRECO, LLC · Class II
smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
vynacron dental resins — VYNACRON DENTAL RESINS, INC. · Class II
HI-I® — FRICKE INTERNATIONAL, INC. · Class II
FREEPRINT crown A1 500g — DETAX GmbH · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Maquira Industria de Produtos Odontologicos S/A

Sources (1)

FDA UDI 361186eb-df1e-44ed-b591-77f32ab3351d 34 fields · synced May 30, 2026