DEVICE: Zinc Phosphate (E23511720)

Device Identifier (DI) Information

Zinc Phosphate
1172
In Commercial Distribution
1172
SHOFU DENTAL CORPORATION
E23511720
HIBCC

1
054618202 *Terms of Use
HY-BOND ZINC LIQUID
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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
Zinc phosphate dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid. 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
EMA Cement, Dental
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K810765 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

3cf29031-2447-4352-b621-364bfd80b210
July 06, 2018
3
September 26, 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: 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
No
No CLOSE

Customer Contact

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760-566-3528
ckaemmerlen@shofu.com
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