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
101
In Commercial Distribution
ADVANTAGE DENTAL PRODUCTS INC
Self-cure resin based impression material for the fabrication of temporary crowns and bridges
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBG | Crown And Bridge, Temporary, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 50 Milliliter |
Device Record Status
bc78381b-4acf-497d-a22e-788cbef4f4eb
October 29, 2021
3
October 21, 2016
October 29, 2021
3
October 21, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
248-391-1625
contact@advantagedentalinc.com
contact@advantagedentalinc.com