FDA.reportPublic FDA data

Citrine

Primary DI
00353045002356
Brand
Citrine
Company
DHARMA RESEARCH, INC.
Model
56-00202
Catalog number
56-00202
Device description
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
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10353045002353PackageGS112In Commercial Distribution
00353045002356PrimaryGS10
00353045002660Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035304500235310353045002353
00353045002356003530450023563530450023560353045002356
00353045002660003530450026603530450026600353045002660

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizing, professionalA substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or 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., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.4Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8778333725info@dharmaresearch.com
+3054829669rcarles@dharmaresearch.com

Regulatory Flags#

DUNS number
078444642
Device count
50
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00353045001083Qartz58-0020058-002002026-10-14
00353045001090Qartz58-0020158-002012026-10-14
00353045001106Qartz58-0020258-002022026-10-14
00353045001113Qartz58-0020358-002032026-10-14
00353045001120Qartz58-0020458-002042026-10-14
00353045001137Qartz58-0020558-002052026-10-14
00353045001144Qartz58-0020658-002062026-10-14
00353045001151Qartz58-0020758-002072026-10-14
00353045001175Qartz58-0020958-002092026-10-14
00353045001182Qartz58-0021058-002102026-10-14
00353045001212Qartz58-0021358-002132026-10-14
00353045001229Qartz58-0021458-002142026-10-14
00353045001236Qartz58-0022458-002242026-10-14
00353045000550Qartz58-0003158-000312026-10-13
00353045000567Qartz58-0003258-000322026-10-13
00353045000598Qartz58-0005158-000512026-10-13
00353045000932Qartz58-0005258-000522026-10-13
00353045000949Qartz58-0005758-000572026-10-13
00353045001168Qartz58-0020858-002082026-10-13
00353045003773Qartz58-0013258-001322026-10-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850006606788Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606795Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606825Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606832Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606863Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606870Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606900Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606917Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606955Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606986Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
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00197998219146Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
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00197998486050Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
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