FDA.reportPublic FDA data

Portux 3D Printing Resin SG x 1000g

Primary DI
07701126901211
Brand
Portux 3D Printing Resin SG x 1000g
Company
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
Model
0027364
Catalog number
0027364
Device description
Portux 3D Printing Resin SG 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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07701126901211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07701126901211077011269012117701126901211

GMDN Terms#

Term, Definition table
TermDefinition
Dental guided surgery reference plateA non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.

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
07701126901204Portux 3D Printing Resin Dental Models002007500200752025-08-11
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

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08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218700OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
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08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
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08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
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