FDA.reportPublic FDA data

PriZma 3D Bio Crown - A2 (500 g)

Primary DI
07898561547804
Brand
PriZma 3D Bio Crown - A2 (500 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
Rx
false
OTC
true
Sterile
false
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
07898561547804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898561547804078985615478047898561547804

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07898561547798PriZma 3D Bio Crown - A2 (250 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
18056865154463ACRY NATURE AFG 6 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
18056865155644ACRY NATURE AFG 6 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
28056865155658ACRY NATURE AFG 8 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
28056865155665ACRY NATURE AFG 8 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
E241VT0120Cavex Instant StoneCavex Holland B.V.PZY2026-03-10
06971437944776UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944783UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944790UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944806UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944813UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944820UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944837UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944844UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944851UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944868UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
07898561547736PriZma 3D Bio Crown - BL (250 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561547743PriZma 3D Bio Crown - BL (500 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561547767PriZma 3D Bio Crown - A1 (250 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561547774PriZma 3D Bio Crown - A1 (500 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561547798PriZma 3D Bio Crown - A2 (250 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561548238PriZma 3D Bio Crown - A3 (250 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
00842326199484TrusanaThe Myerson Company LimitedPZY2025-08-26
00842326199491TrusanaThe Myerson Company LimitedPZY2025-08-26
00842326199507TrusanaThe Myerson Company LimitedPZY2025-08-26
00842326199514TrusanaThe Myerson Company LimitedPZY2025-08-26
00842326199521TrusanaThe Myerson Company LimitedPZY2025-08-26
00842326199538TrusanaThe Myerson Company LimitedPZY2025-08-26
D0019064150LucitoneDentsply International Inc.PZY2025-07-01
D0019064170LucitoneDentsply International Inc.PZY2025-07-01
00842326199576Trusana1The Myerson Company LimitedPZY2025-02-28