FDA.reportPublic FDA data

Citrine

Primary DI
00353045002363
Brand
Citrine
Company
DHARMA RESEARCH, INC.
Model
56-00204
Catalog number
56-00204
Device description
Citrine 5% Sodium Fluoride Varnish, Bubble Gum 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
10353045002360PackageGS112In Commercial Distribution
00353045002363PrimaryGS10
00353045002653Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035304500236010353045002360
00353045002363003530450023633530450023630353045002363
00353045002653003530450026533530450026530353045002653

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
00353045000628Jade20-0000520-000052016-10-07
00353045000635Jade20-0000220-000022016-10-07
00353045000642Jade20-0000320-000032016-10-07
00353045000659Jade20-0000420-000042016-10-07
00353045000666Jade20-0000120-000012016-10-07
00353045000673Jade20-0000620-000062016-10-07
00353045000680Jade20-0000720-000072016-10-07
00353045000697Jade20-0000820-000082016-10-07
00353045000703Jade20-0000920-000092016-10-07
00353045002127Jade20-0001620-000162016-10-07
00353045002134Jade20-0009120-000912016-10-07
00353045000710Jade20-0001020-000102016-10-07
00353045002349Citrine56-0020056-002002016-10-07
00353045002356Citrine56-0020256-002022016-10-07
10353045000625Jade20-0000520-000052016-10-07
10353045000632Jade20-0000220-000022016-10-07
10353045000649Jade20-0000320-000032016-10-07
10353045000656Jade20-0000420-000042016-10-07
10353045000663Jade20-0000120-000012016-10-07
10353045000670Jade20-0000620-000062016-10-07

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Primary DI, Brand, Company table
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506058610873033M™ Clinpro™3M COMPANYLBH2025-10-15
10818207025064ReminGelVista DentalLBH2025-10-09
07615208299373Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10
07615208292893Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-03-20
00302730003178D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003192D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003208D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003215D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003222D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
07615208474459Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-04-05
07615208474091Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-03-25
106058610839633M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839703M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839873M™ Clinpro™3M COMPANYLBH2023-12-14
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10810111542873FluoroCalBISCO INC.LBH2023-12-11
10810111542897FluoroCalBISCO INC.LBH2023-12-11
10371347011590Advance Dental ProductsThe Atlanta Dental Supply CompanyLBH2023-11-29
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10732224005567Sparkle V Sodium Fluoride Varnish, CaramelCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005574Sparkle V Sodium Fluoride Varnish, MelonCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224000302Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
10732224000319Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
20035000992974Toms Sensitive + Whitening Fluoride-Free Toothpaste TOM'S OF MAINE, INC.LBH2023-06-02
20810063753928Safco CleanCare Essential Prophy PasteSAFCO DENTAL SUPPLY CO.LBH2022-12-02