DEVICE: ParaPost (D661P58611)

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Device Record History
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Device Identifier (DI) Information
ParaPost
P5861
In Commercial Distribution

COLTENE/WHALEDENT INC
D661P58611
HIBCC

10
622185718 *Terms of Use
ParaPost ParaForm Trial Kit
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
42344 Dental mould
A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DZN Instruments, Dental Hand
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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
cbf667e1-377d-4c85-b410-eca6b93534ce
March 11, 2019
1
February 26, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: D661P58610 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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