FDA.reportPublic FDA data

Varnish America 0.25ml Box / 32 White Raspberry

Primary DI
20302730701115
Brand
Varnish America 0.25ml Box / 32 White Raspberry
Company
YOUNG DENTAL MANUFACTURING I, LLC
Model
07-0111
Device description
32 count box, 0.25ml each
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
20302730701115PackageGS172In Commercial Distribution
10302730701118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2030273070111520302730701115
1030273070111810302730701118

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006309355
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00302730003383Young Dental2969972025-09-05
10302732969509Young Core2969502025-06-11
00302730003307Young Dental2969062025-03-07
20302732311022Young Dental2311022311022025-02-17
20302732322004Young Dental2322002322002025-02-17
10302732322106Young Dental2322102322102025-02-17
10302732322250Young Dental2322252322252025-02-17
10302732330040Young Dental2330042330042025-02-17
00302732331026Young Dental2331022331022025-02-17
20302732342002Young Dental2342002342002025-02-17
10302732342104Young Dental2342102342102025-02-17
10302732342258Young Dental2342252342252025-02-17
10302732957186Young Dental2957182957182025-02-17
00302730003314Young Core2969272969272025-01-06
00302730003321Young Core2969282969282025-01-06
00302730003338Young Core2969292969292025-01-06
00302730003345Young Core2969302969302025-01-06
00302730003352Young Core2969312969312025-01-06
00302730003369Young Core2969322969322025-01-06
00302730003376Young Select2969332969332025-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7714227200BG0Dental CityICP, INC.LBH2026-03-24
D7714227200M0Dental CityICP, INC.LBH2026-03-24
D7714227200ML0Dental CityICP, INC.LBH2026-03-24
D771422750ML0Dental CityICP, INC.LBH2026-03-24
G402DENTOCLUDE1Dentoclude FCUMBERLAND BIOTHERAPEUTICS LLCLBH2026-03-19
09336472038212RIVA STARSDI LIMITEDLBH2026-02-16
09336472038366RIVA STAR AQUASDI LIMITEDLBH2026-02-16
09336472038403RIVA STAR AQUASDI LIMITEDLBH2026-02-16
09336472038441RIVA STARSDI LIMITEDLBH2026-02-16
00883205044068EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044075EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044082EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044099EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044105EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044112EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044129EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044136EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00858290006970FluoriMax 2.5% NaF demo pack ELEVATE ORAL CARE, LLCLBH2026-01-28
00827854027126Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
00827854027577Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
00883205044143EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044150EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044167EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044174EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00850006606719Wonderful DentalRoses and Rubies, LLCLBH2025-09-19
00850006606726Wonderful DentalRoses and Rubies, LLCLBH2025-09-19
00883205033000EnamelastULTRADENT PRODUCTS, INC.LBH2025-08-23
00883205032829ConsepsisULTRADENT PRODUCTS, INC.LBH2025-08-19
00883205032843ConsepsisULTRADENT PRODUCTS, INC.LBH2025-08-19
07615208545753Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10