DEVICE: MI Paste™ (D6584222651)
Device Identifier (DI) Information
MI Paste™
422265
In Commercial Distribution
422265
Gc America Inc.
422265
In Commercial Distribution
422265
Gc America Inc.
MI Paste™ 10-pack, 10 tubes (40g each) of MI Paste Assorted has 2 tubes of each flavor (melon, mint, strawberry, tutti-frutti & vanilla)
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? |
---|---|---|---|---|
45232 | Dental coating, tooth-desensitizing |
A substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EJR | AGENT, POLISHING, ABRASIVE, ORAL CAVITY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K042200 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 8 and 25 Degrees Celsius |
Storage Environment Temperature: between 46 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a2c96c74-6446-4d52-a30f-8ac34abb5909
February 07, 2019
4
February 10, 2017
February 07, 2019
4
February 10, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D6584222652 | 30 | D6584222651 | In Commercial Distribution |
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(708)597-0900
customerservice@gcamerica.com
customerservice@gcamerica.com