DEVICE: Citrine (00353045002356)
Device Identifier (DI) Information
Citrine
56-00202
In Commercial Distribution
56-00202
DHARMA RESEARCH, INC.
56-00202
In Commercial Distribution
56-00202
DHARMA RESEARCH, INC.
Citrine 5% Sodium Fluoride Varnish, Vanilla Cake Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Brushes, 1 Doctor Instruction Insert and 50 Patient Instruction Inserts
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
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 |
---|---|
LBH | Varnish, Cavity |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 20 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 0.4 Milliliter |
Device Record Status
554da367-2372-4b1a-9397-8e478f23ab0d
February 07, 2019
3
October 07, 2016
February 07, 2019
3
October 07, 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 |
---|---|---|---|---|---|
10353045002353 | 12 | 00353045002356 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00353045002660
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8778333725
info@dharmaresearch.com +3054829669
rcarles@dharmaresearch.com
info@dharmaresearch.com +3054829669
rcarles@dharmaresearch.com