DEVICE: Alphaseal Liner (D83610211)

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Device Identifier (DI) Information

Alphaseal Liner
1021
1021
DENT ZAR, INC.
D83610211
HIBCC
4
Alphaseal is a visible light cured cavity liner. It has a light paste consistency to facilitate the application. OUTSTANDING FEATURES OF THE PRODUCT: • Fast and easy to apply • Economical • Compatible with all restoratives and cements • Mechanically strong and insoluble in oral fluids • Long shelf-life; no refrigeration required • Resistant to etching agents • X-ray opaque • Simplified handling; direct to tooth application
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Calcium hydroxide dental cement A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EBF Material, Tooth Shade, Resin
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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 Status

In Commercial Distribution
September 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
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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: D83610210 CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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No Customer Contact currently defined
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