DEVICE: YAMAHACHI PMMA DISK (04582275717044)

Device Identifier (DI) Information

YAMAHACHI PMMA DISK
98.5mm*20mm, D2
In Commercial Distribution

YAMAHACHI DENTAL MFG.,CO.
04582275717044
GS1

1
693430001 *Terms of Use
No description.
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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 crown/bridge resin, temporary A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
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FDA Product Code

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Product Code Product Code Name
EBG Crown And Bridge, Temporary, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151764 000
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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

7c27416b-e1a8-4285-aea2-4b0fa5b28cad
July 06, 2018
3
February 03, 2018
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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

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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