DEVICE: ProBase (DIVO5314801)

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Device Identifier (DI) Information

ProBase
531480
531480
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
DIVO5314801
HIBCC
2
denture base materials
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Denture base resin, cured A resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth); it may also be used to manufacture occlusal splints/night guards. It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that undergoes polymerization (or vulcanization) to harden under the appropriate conditions with an appropriate catalyst. Reinforcing fillers may be included in the resin to increase its strength and/or durability. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
EBI RESIN, DENTURE, RELINING, REPAIRING, REBASING
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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 Status

In Commercial Distribution
November 24, 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: DIVO5314800 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
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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