FDA.reportPublic FDA data

AcryFree cartridges Opaque Light Pink

Primary DI
07290110500993
Brand
AcryFree cartridges Opaque Light Pink
Company
PERFLEX LTD
Model
25mm Diam. Extra Large 107mm long
Catalog number
332513
Device description
box of 6 identical cartridges sealed in a vacuum bag ;cartridge dimensions : 25mm diameter ; 107mm long ;each cartridge filled with 31Gr of AcryFree Opaque Light Pink Thermoplastic pellets.
Published
2022-11-07
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
07290110500993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110500993072901105009937290110500993

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
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

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08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
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