FDA.reportPublic FDA data

Perflex Biosens

Primary DI
07290110501440
Brand
Perflex Biosens
Company
PERFLEX LTD
Model
Purple Pink 200gr. jar
Catalog number
411008
Device description
Biosens Thermoplastic pellets for dentures by injection moldingShade Purple Pink200gr. net filled in jar and packed in box
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

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150454000Acryfree Denture Base Material and Biosens Denture Base MaterialPerflex2015-05-26EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110501440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110501440072901105014407290110501440

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

Contacts#

Phone, Email table
PhoneEmail
+97298825473vidal@perflexltd.com

Regulatory Flags#

DUNS number
532176000
Device count
1
Lot or batch
true
Manufacturing date on label
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
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
07290110501570Biosens cartridges Clear25mm Diam. Extra Large 107mm long41125072022-11-08
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