FDA.reportPublic FDA data

Portux 3D Printing Resin Dental Models

Primary DI
07701126901204
Brand
Portux 3D Printing Resin Dental Models
Company
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
Model
0020075
Catalog number
0020075
Device description
Portux 3D Printing Resin Dental Models x 1000g
Published
2025-08-11
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07701126901204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07701126901204077011269012047701126901204

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
880141023
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
07701126631194Opti-Cryl Pour Acrylic Original X 22 lb002260500226052026-04-23
07701126900948Portux 3D Printing Resing Try-In BL40028444 0028444 2025-08-11
07701126900955PORTUX 3D Printing Resin Try-In BL4002804500280452025-08-11
07701126900962Portux 3D Printing Resin Try-In 002611000289612025-08-11
07701126900979Portux 3D Printing Resin Try-In.002896700289672025-08-11
07701126901167Portux 3D Printing Resin Try-In002896600289662025-08-11
07701126901174PORTUX 3D Printing Resin Try-In A1002896000289602025-08-11
00770112663119Opti-Cryl Pour Acrylic Original X 22 lb002260500226052024-05-08
07701126901075Portux 3D Printing Resin Basic Gray x 500g002913200291322025-08-11
07701126901150Portux 3D Printing Resin Cast002843900284392025-08-11
07701126901211Portux 3D Printing Resin SG x 1000g0027364 0027364 2025-08-11
07701126901228Portux 3D Printing Resin Cast002736600273662025-08-11
07701126901235Portux 3D Printing Resin Model 2.0002913400291342025-08-11
07701126615842Opti-Cryl Pour Acrylic Liquid X 8 oz1087451087452024-05-08
07701126615897Novacryl Self Curing Acrylic Liquid X 8 oz002570700257072024-05-08
07701126626336O-Cryl Self Curing Acrylic Shade White X 1 lb002010300201032024-05-08
07701126626343O-Cryl Self Curing Acrylic Shade Clear X 1 lb002319400231942024-05-08
07701126626350O-Cryl Self Curing Acrylic Liquid X 8 oz002319600231962024-05-08
07701126626374O-Cryl Self Curing Acrylic Shade Clear X 5 lb0024452 00244522024-05-08
07701126631156Opti-Cryl Pour Acrylic Original X 1 lb002260000226002024-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D14307560147448590Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBH2026-07-23
00840456224427JMUJMU DENTAL, INCEBH2026-07-20
00840456224434JMUJMU DENTAL, INCEBH2026-07-20
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09
00840456209349JMUJMU DENTAL, INCEBH2026-07-09
00840456209356JMUJMU DENTAL, INCEBH2026-07-09
00840456214138JMUJMU DENTAL, INCEBH2026-07-09
00840456214145JMUJMU DENTAL, INCEBH2026-07-09
00840456214152JMUJMU DENTAL, INCEBH2026-07-09
00840456214169JMUJMU DENTAL, INCEBH2026-07-09
00840456214176JMUJMU DENTAL, INCEBH2026-07-09
00840456214183JMUJMU DENTAL, INCEBH2026-07-09
00840456214190JMUJMU DENTAL, INCEBH2026-07-09
00840456214206JMUJMU DENTAL, INCEBH2026-07-09
00840456214213JMUJMU DENTAL, INCEBH2026-07-09
00840456214220JMUJMU DENTAL, INCEBH2026-07-09
00840456223680JMUJMU DENTAL, INCEBH2026-07-09
00840456223697JMUJMU DENTAL, INCEBH2026-07-09
00840456223703JMUJMU DENTAL, INCEBH2026-07-09
00840456223710JMUJMU DENTAL, INCEBH2026-07-09