FDA.reportPublic FDA data

Biosens cartridges Clear

Primary DI
07290110501570
Brand
Biosens cartridges Clear
Company
PERFLEX LTD
Model
25mm Diam. Extra Large 107mm long
Catalog number
4112507
Device description
box of 6 identical cartridges sealed in a vacuum bag ;cartridge dimensions : 25mm diameter ; 107mm long ;each cartridge filled with 31Gr of Biosens Clear Thermoplastic pellets.
Published
2022-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110501570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110501570072901105015707290110501570

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532176000
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
07290110501372Perflex BiosensLight Pink1kg jar4110012022-11-08
07290110501389Perflex BiosensLight Pink 200gr. jar4110022022-11-08
07290110501433Perflex BiosensPurple Pink 1kg jar4110072022-11-08
07290110501440Perflex BiosensPurple Pink 200gr. jar4110082022-11-08
07290110501457Perflex BiosensOpaque Pink1kg jar4110092022-11-08
07290110501464Perflex BiosensOpaque Pink 200gr. jar4110102022-11-08
07290110501471Perflex BiosensLight Pink Clear 1kg jar4110112022-11-08
07290110501488Perflex BiosensLight Pink Clear 200gr. jar4110122022-11-08
07290110501495Perflex BiosensStandard Pink Clear 1kg jar4110132022-11-08
07290110501501Perflex BiosensStandard Pink Clear 200gr. jar4110142022-11-08
07290110501518Biosens cartridges Light Pink25mm Diam. Extra Large 107mm long41125012022-11-08
07290110501525Biosens cartridges Light Pink25mm Diam. Large 98mm long41125022022-11-08
07290110501532Biosens cartridges Light Pink25mm Diam. Medium 73mm long41125032022-11-08
07290110501549Biosens cartridges Standard Pink25mm Diam. Extra Large 107mm long41125042022-11-08
07290110501587Biosens cartridges Clear25mm Diam. Large 98mm long41125082022-11-08
07290110501594Biosens cartridges Clear25mm Diam. Medium 73mm long41125092022-11-08
07290110501600Biosens cartridges Purple Pink25mm Diam. Extra Large 107mm long41125102022-11-08
07290110501617Biosens cartridges Purple Pink25mm Diam. Large 98mm long41125112022-11-08
07290110501624Biosens cartridges Purple Pink25mm Diam. Medium 73mm long41125122022-11-08
07290110501631Biosens cartridges Opaque Pink25mm Diam. Extra Large 107mm long41125132022-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147451840Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
EPOLPMMP10090Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10100Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10110Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10120Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10130Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17