FDA.reportPublic FDA data

PriZma 3D Bio Crown - A2 (250 g)

Primary DI
07898561547798
Brand
PriZma 3D Bio Crown - A2 (250 g)
Company
Maquira Industria de Produtos Odontologicos S/A
Model
PriZma 3D Bio Crown
Catalog number
80483749005
Device description
PRIZMA 3D BIO CROWN is a UVA/UVB light cured resin exclusively for use in 3D printers. Indicated for the manufacted of surgical guides for implants and others.
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898561547798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898561547798078985615477987898561547798

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
679266866
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898570928151PriZma 3D Bio Splint Soft - Colorless (250 g)PRIZMA 3D BIO SPLINT 804837490082025-09-12
07898570928168PriZma 3D Bio Splint Soft - Colorless (500 g)PRIZMA 3D BIO SPLINT 804837490082025-09-12
07898570928175PriZma 3D Bio Splint Soft - Colorless (1000 g)PRIZMA 3D BIO SPLINT 804837490082025-09-12
07898561546999PriZma 3D Bio Splint - Transparent (500 g)PriZma 3D Bio Splint2025-09-05
07898561547002PriZma 3D Bio Splint - Transparent (250 g)PriZma 3D Bio Splint804837400012025-09-05
07898561547019PriZma 3D Bio Guide - Ambar (1000 g)PriZma 3D Bio Guide804837400032025-09-05
07898561547026PriZma 3D Bio Guide - Ambar (500 g)PriZma 3D Bio Guide804837400032025-09-05
07898561547033PriZma 3D Bio Guide - Ambar (250 g)PriZma 3D Bio Guide804837400032025-09-05
07898561547330PriZma 3D Bio Ortho IBT (1000 g)PriZma 3D Bio Ortho804837400042025-09-05
07898561547347PriZma 3D Bio Ortho IBT (500 g)PriZma 3D Bio Ortho804837400042025-09-05
07898561547354PriZma 3D Bio Ortho IBT (250 g)PriZma 3D Bio Ortho804837400042025-09-05
07898561547736PriZma 3D Bio Crown - BL (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547743PriZma 3D Bio Crown - BL (500 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547767PriZma 3D Bio Crown - A1 (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547774PriZma 3D Bio Crown - A1 (500 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547804PriZma 3D Bio Crown - A2 (500 g)PriZma 3D Bio Crown804837490052025-09-05
07898561548238PriZma 3D Bio Crown - A3 (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561549020PriZma 3D Bio Crown Diamond - BL (300 g)PriZma 3D Bio Crown Diamond804837490072025-09-05
07898561549037PriZma 3D Bio Crown Diamond A1 (300 g)PriZma 3D Bio Crown Diamond804837490072025-09-05
07898561549044PriZma 3D Bio Crown Diamond - A2 (300 g)PriZma 3D Bio Crown Diamond804837490072025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.PZY2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147451840Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D800ZBAC6405A010Printer Resin Denture Tooth Temporary A1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A020Printer Resin Denture Tooth Temporary A2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A030Printer Resin Denture Tooth Temporary A3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A040Printer Resin Denture Tooth Temporary A4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A350Printer Resin Denture Tooth Temporary A3,5 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B010Printer Resin Denture Tooth Temporary B1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B020Printer Resin Denture Tooth Temporary B2 (500g)ZIRKONZAHN SRLPZY2026-05-20