DEVICE: T-Crystal (07290110500023)

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Device Identifier (DI) Information

T-Crystal
Light Pink
11002
PERFLEX LTD
07290110500023
GS1
1
T-Crystal Thermoplastic pellets for Dentures by Injection moulding Shade Light Pink 200gr net jar
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Denture base resin, thermoplastic A thermoplastic material intended to be used in the dental laboratory to manufacture a temporary, partial, or fully-removable denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth); it may also be used to manufacture occlusal splints and night guards. The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank] 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 device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 25, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+97298825473
vidal@perflexltd.com
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