DEVICE: Ceramic Dentine D2+ (20 g) (D800KEAA6171)

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Device Identifier (DI) Information

Ceramic Dentine D2+ (20 g)
KEAA6171

ZIRKONZAHN SRL
D800KEAA6171
HIBCC
1
Content: 20 g Very opaque and chromatic ceramic masses for reduction of the grey value in the crown
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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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
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

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Product Code Product Code Name
EIH POWDER, PORCELAIN
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Sterilization

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

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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
November 04, 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
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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None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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+390474066660
info@zirkonzahn.com
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