DEVICE: Dentorium (05056079000811)
Device Identifier (DI) Information
Dentorium
Anterior 1N upper 66
In Commercial Distribution
D1NU66
WRIGHT HEALTH GROUP LIMITED
Anterior 1N upper 66
In Commercial Distribution
D1NU66
WRIGHT HEALTH GROUP LIMITED
Polymer Teeth - Set
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Resin artificial teeth | Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELM | Denture, Plastic, Teeth |
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 |
---|
No Device Sizes |
Device Record Status
fcdef9d6-f1bf-4969-8eb5-bd39e486dd23
March 29, 2018
2
October 01, 2016
March 29, 2018
2
October 01, 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)847-4209
mail@dentorium.com
mail@dentorium.com