FDA.reportPublic FDA data

Young Dental

Primary DI
00302730003307
Brand
Young Dental
Company
YOUNG DENTAL MANUFACTURING I, LLC
Model
296906
Device description
ClearDefense Silver Fluoride Hypersensitivity Varnish
Published
2025-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHRDiammine Silver Fluoride Dental Hypersensitivity VarnishDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241041000Silver Fluoride Hypersensitivity VarnishYoung Dental Manufacturing Co. 1, LLC2025-02-28PHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00302730003307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00302730003307003027300033073027300033070302730003307

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature35 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 325-1881customerservice@younginnovations.com

Regulatory Flags#

DUNS number
006309355
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00302730001723Young2962672962672026-05-15
00302730001730Young2962652962652026-05-15
10302732957827Varnish Pen - Assorted2957822017-07-17
10302730701309Varnish America 0.25ml Box / 200 White Bubblegum07-01302017-08-31
10302732958350Varnish Pen - Mint2958352017-07-17
10302732958367Varnish Pen - Assorted2958362017-07-17
00302730002508Zooby2962012962012022-10-16
10302733701016Etching Gel 5mL/20 Tips3701012016-09-23
10302733701047Etching Gel 5 mL/40 Tips3701042016-09-23
00302730003383Young Dental2969972025-09-05
00302732322253Young Dental2322252322252025-02-17
00302732342251Young Dental2342252342252025-02-17
10302732958305Barrier Sleeve, Young Infinity Cordless Handpiece, 25ct2958302018-05-25
10302732958312Barrier Sleeve, Young Infinity Cordless Handpiece, 500ct2958312018-05-25
10302736702508Short Pen Sleeve6702502017-10-27
10302736703505Light Handle Sleeve6703502017-10-27
10302736704502Low Speed Handpiece Sleeve6704502017-10-27
00302730002348Young2958302958302022-10-16
00302730002355Young2958312958312022-10-16
00302730002362Denticator6700506700502022-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079280151HexaHexa DentalPHR2026-01-21
00850079280168HexaHexa DentalPHR2026-01-21
00302730003383Young DentalYOUNG DENTAL MANUFACTURING I, LLCPHR2025-09-05
00858290006802Advantage ArrestELEVATE ORAL CARE, LLCPHR2025-07-21
00858290006819Advantage ArrestELEVATE ORAL CARE, LLCPHR2025-07-21
00858290006826Advantage ArrestELEVATE ORAL CARE, LLCPHR2025-07-21
00858290006956Advantage Arrest ELEVATE ORAL CARE, LLCPHR2025-06-11
00810118104503NuSmile NuNamel 38% Silver Diamine Fluoride (SDF)NUSMILE, LTD.PHR2025-03-10
00810118104510Avalon Biomed 38% Silver Diamine Fluoride (SDF)NUSMILE, LTD.PHR2025-03-10
00817051023625SilverSenseCENTRIX, INC.PHR2023-12-13
00817051023632SilverSenseCENTRIX, INC.PHR2023-12-13
00858290006888Advantage Arrest ELEVATE ORAL CARE, LLCPHR2023-07-21
00850023750570Hexa DentalHexa DentalPHR2022-02-09
00850023750587Hexa DentalHexa DentalPHR2022-02-09
00858290006628Advantage Arrest ELEVATE ORAL CARE, LLCPHR2020-12-21
00858290006604Advantage Arrest ELEVATE ORAL CARE, LLCPHR2020-12-21
00858290006611Advantage Arrest ELEVATE ORAL CARE, LLCPHR2020-12-21
00858290006161Advantage Arrest ELEVATE ORAL CARE, LLCPHR2020-12-21
00858290006130Advantage ArrestELEVATE ORAL CARE, LLCPHR2016-11-01
00858290006000Advantage ArrestELEVATE ORAL CARE, LLCPHR2016-09-26