DEVICE: Diamond Polish Mint (00883205104298)
Device Identifier (DI) Information
Diamond Polish Mint
5541
In Commercial Distribution
5541
ULTRADENT PRODUCTS, INC.
5541
In Commercial Distribution
5541
ULTRADENT PRODUCTS, INC.
Diamond Polish Mint 1.0 Micron Refill
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? |
---|---|---|---|---|
31857 | Ertapenem susceptibility testing disc IVD |
A susceptibility testing disc impregnated with a defined amount of the antimicrobial ertapenem, intended to be used to determine the antimicrobial susceptibility of a specific microorganism isolated from a clinical specimen by culture, using a disc diffusion method.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBF | MATERIAL, TOOTH SHADE, RESIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K921407 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 18 and 29 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Particle Size Diameter 1.0 Micron |
Device Record Status
ef3402a2-477c-4333-8575-68dacb542e48
July 06, 2018
3
September 22, 2016
July 06, 2018
3
September 22, 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(801)572-4200
customerservice@ultradent.com
customerservice@ultradent.com