DEVICE: Reduced Set Ceramic Tissue (D800KEAA6281)

Device Identifier (DI) Information

Reduced Set Ceramic Tissue
KEAA6281
In Commercial Distribution

ZIRKONZAHN SRL
D800KEAA6281
HIBCC

1
564251911 *Terms of Use
Content: 6 x tissue coloured ceramics with reduced amounts (10 g each) Colour scale from very bright (Tissue 1) to very dark (Tissue 6)
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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
Dental appliance 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 used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
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FDA Product Code

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Product Code Product Code Name
EIH POWDER, PORCELAIN
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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
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 Record Status

d17ad9dc-c8b2-4f45-a6f5-0e6ba4fb90a7
July 24, 2018
3
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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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+390474066660
info@zirkonzahn.com
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