DEVICE: UltraPrint-Dental Temp C&B UV (06971437940129)

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Device Record History
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Device Identifier (DI) Information
UltraPrint-Dental Temp C&B UV
2.0
In Commercial Distribution

GUANGZHOU HEYGEARS IMC.INC
06971437940129
GS1

1
418561545 *Terms of Use
UltraPrint-Dental Temp C&B UV, 250g/bottle, A3
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Device Characteristics
MR Safe
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?
45236 Temporary dental crown/bridge resin
A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EBG Crown And Bridge, Temporary, Resin
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K213643 000
No 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
85a0c0c4-ddd1-4650-948d-5305dbdb4281
January 27, 2022
1
January 19, 2022
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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