FDA.reportPublic FDA data

PriZma 3D Bio Crown Diamond - A2 (300 g)

Primary DI
07898561549044
Brand
PriZma 3D Bio Crown Diamond - A2 (300 g)
Company
Maquira Industria de Produtos Odontologicos S/A
Model
PriZma 3D Bio Crown Diamond
Catalog number
80483749007
Device description
PRIZMA 3D BIO CROWN DIAMOND is a nanohybrid resin for preparation of dental crowns.
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
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898561549044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898561549044078985615490447898561549044

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817169029304Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELM2026-03-11
05056079069658Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070036Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070043Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070050Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070067Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070074Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070081Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070098Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070449Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070456Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070463Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070470Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070487Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070494Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070500Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070517Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070524Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070531Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070548Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070555Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070562Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070579Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070586Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070593Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070609Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070616Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070623Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070630Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070647Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18