DEVICE: Polysil Transbite (07540196000604)

Device Identifier (DI) Information

Polysil Transbite
SH-301
In Commercial Distribution
SH-301
Scican Ltd
07540196000604
GS1

1
204137145 *Terms of Use
Transparent bite registraton material. Ideal for performing occlusal templates, labial matrices and other custom matrices for light cured materials.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Silicone dental impression material An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
ELW Material, Impression
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Store at normal room temperature (65°-73°F / 18°-23°C).
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d571b48b-ea69-490a-b3e2-7b6206a8a1b6
March 29, 2018
2
August 02, 2016
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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
17540196000601 2 07540196000604 In Commercial Distribution Carton
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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18006677733
tboyce@scican.com
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