DEVICE: upcera Dental Zirconia Pre-Shaded Blank (06970596164155)

Device Identifier (DI) Information

upcera Dental Zirconia Pre-Shaded Blank
C2-D95-12
In Commercial Distribution

Liaoning Upcera Co.,Ltd.
06970596164155
GS1

1
548214192 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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 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 [?]
K141724 000
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Sterilization

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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 Record Status

fac38ad9-6459-4da5-bf31-4879e55148bb
July 24, 2018
4
January 05, 2017
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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
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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

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Yes
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Yes
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Customer Contact

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No Customer Contact currently defined
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