DEVICE: MatrixTemp Temporary Crown and Bridge Material (00859787002017)

Device Identifier (DI) Information

MatrixTemp Temporary Crown and Bridge Material
101
In Commercial Distribution

ADVANTAGE DENTAL PRODUCTS INC
00859787002017
GS1

1
607859147 *Terms of Use
Self-cure resin based impression material for the fabrication of temporary crowns and bridges
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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?
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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Use with adequate ventilation and store away from oxidizing materials
Storage Environment Temperature: less than 73 Degrees Fahrenheit
Handling Environment Temperature: less than 73 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 50 Milliliter
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Device Record Status

bc78381b-4acf-497d-a22e-788cbef4f4eb
October 29, 2021
3
October 21, 2016
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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
10859787002014 12 00859787002017 In Commercial Distribution Box
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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

[?]
248-391-1625
contact@advantagedentalinc.com
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