DEVICE: Henry Schein (00304040016824)

Device Identifier (DI) Information

Henry Schein
2020376
In Commercial Distribution
2020376
HENRY SCHEIN, INC.
00304040016824
GS1

1
012430880 *Terms of Use
CHANNELS MTA CEMENT SAMPL EA
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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
Hygroscopic dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is available as a powder intended to be either mixed water prior to application or react with dentinal fluid in situ. 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 [?]
K112046 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
Weight: 0.28 Gram
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Device Record Status

fd0af01d-b491-4cfd-80b9-96798b2b70f3
July 06, 2018
3
September 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
10304040016821 2 00304040016824 In Commercial Distribution
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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
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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