DEVICE: TEMP TABS (D0331430200)

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Device Record History
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Device Identifier (DI) Information
TEMP TABS
143020
In Commercial Distribution

DMG AMERICA, LLC
D0331430200
HIBCC

1
106792427 *Terms of Use
FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
34799 Composite dental impression material
A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.
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 [?]
K033227 000
No CLOSE

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

[?]
Storage and Handling
Handling Environment Temperature: less than 145 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
11ced5f2-91bc-4506-b742-9f15f01eedba
April 28, 2025
1
April 18, 2025
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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

[?]
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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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