DEVICE: Henry Schein (00304040009543)

Device Identifier (DI) Information

Henry Schein
9011617
In Commercial Distribution
9011617
HENRY SCHEIN, INC.
00304040009543
GS1

1
012430880 *Terms of Use
Zirlux 16+ D4 coloring liquid
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Dental prosthesis fabrication material, ceramic A dental material made of ceramic materials e.g., zirconium oxide, intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is and is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology.
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FDA Product Code

[?]
Product Code Product Code Name
EIH POWDER, PORCELAIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141723 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: between 0 and 30 Degrees Celsius
Special Storage Condition, Specify: Dry storage space
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 50 Milliliter
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Device Record Status

9b04c4d7-cc4b-4dfb-a030-287a7c4f6792
July 06, 2018
3
September 24, 2016
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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)

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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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