DEVICE: PMMA disc (D00180822160)
Device Identifier (DI) Information
PMMA disc
Shaded PMMA C4, 16mm
In Commercial Distribution
8082216
Dentsply International Inc.
Shaded PMMA C4, 16mm
In Commercial Distribution
8082216
Dentsply International Inc.
No description.
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? |
---|---|---|---|---|
31783 | Temporary dental crown/bridge |
A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].
|
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 16 Millimeter |
Device Record Status
87d7e9eb-43c8-4c14-98f1-753d6895586f
October 29, 2021
3
November 23, 2016
October 29, 2021
3
November 23, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(800)243-1942
54660
Prosthetics-Regulatory@dentsply.com
Prosthetics-Regulatory@dentsply.com