DEVICE: Henry Schein (00304040037089)

Device Identifier (DI) Information

Henry Schein
9003663
In Commercial Distribution
9003663
HENRY SCHEIN, INC.
00304040037089
GS1

1
012430880 *Terms of Use
Calcium Hydroxide Temporary Root Filling Material
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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
Calcium hydroxide suspension A very basic (high pH) calcium hydroxide (Ca(OH)2) solution (also known as slaked lime or milk of lime) used in dentistry for a variety of purposes including to flush and disinfect root canals and crowns/bridges before final insertion, and to change the viscosity and/or moisten a temporary tooth filling material. It may also encourage the change of fibroblasts (cells which form the connective tissue of the body) into odontoblast-like cells to produce reparative dentin. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
KIF RESIN, ROOT CANAL FILLING
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

Yes
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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

daace21d-530d-48ca-9888-407a6c169c13
March 29, 2018
2
January 12, 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
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
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Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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