FDA.report

T-Crystal

Primary DI
07290110500016
Brand
T-Crystal
Company
PERFLEX LTD
Model
Light Pink
Catalog number
11001
Device description
T-Crystal Thermoplastic pellets for Dentures by Injection moulding Shade Light Pink 1kg net in jar
Published
2017-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290110500016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290110500016072901105000167290110500016

GMDN Terms

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

Contacts

PhoneEmail
+972098825473vidal@perflexltd.com

Regulatory Flags

DUNS number
532176000
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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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