DEVICE: Zirlux (00304040151495)

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Device Record History
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Device Identifier (DI) Information
Zirlux
9012701
In Commercial Distribution
9012701
HENRY SCHEIN, INC.
00304040151495
GS1

1
012430880 *Terms of Use
ZIRLUX ACETAL MILLING DISC
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45236 Temporary dental crown/bridge resin
A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EBI RESIN, DENTURE, RELINING, REPAIRING, REBASING
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K172407 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: less than 193 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Height: 15 Millimeter
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Device Record Status
9697e8d7-1db8-44c6-9951-cb704dca366e
October 29, 2021
2
March 11, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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