DEVICE: Pulpdent® Paste (D701PSYK2)

Device Identifier (DI) Information

Pulpdent® Paste
PSYK
In Commercial Distribution

PULPDENT CORPORATION
D701PSYK2
HIBCC

1
001006089 *Terms of Use
KIT: 3 mL syringe with 24 needles (18 gauge blunt) -Calcium Hydroxide Paste, Radiopaque
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38770 Dental pulp-capping material
A dental compound designed to cover an exposed or nearly-exposed dental pulp (e.g., due to deep cavities) to provide protection against external influences and to promote healing. This compound does not have dental cement or dental cavity liner intended uses. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
EJK Liner, Cavity, Calcium Hydroxide
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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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

06e7b7ca-4814-4779-a31a-8eaefbfcbebe
March 29, 2018
2
August 25, 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)

[?]
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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