FDA.reportPublic FDA data

Young

Primary DI
00302732950661
Brand
Young
Company
YOUNG DENTAL MANUFACTURING I, LLC
Model
295066
Catalog number
13226938
Device description
Young Centwins, Anatomically Contoured Fluoride Trays - Hinged, Large, 50ct - 13226938
Published
2022-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMTTRAY, FLUORIDE, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMTTray, Fluoride, DisposableDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10302732950668PackageGS150In Commercial Distribution
20302732950665PackageGS18In Commercial Distribution
00302732950661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030273295066810302732950668
2030273295066520302732950665
00302732950661003027329506613027329506610302732950661

GMDN Terms#

Term, Definition table
TermDefinition
Fluoride gel trayA device typically made of styrofoam that is used to apply fluoride topically to the teeth. The device is designed to conform to the human mouth; a patient bites down on the device after it has been filled with a fluoride gel or solution for application.

Contacts#

Phone, Email table
PhoneEmail
+1(800) 325-1881customerservice@younginnovations.com

Regulatory Flags#

DUNS number
006309355
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing 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
00850043381570Buffalo DentalBuffalo Dental Manufacturing Co., Inc.KMT2026-04-10
00850043381587Buffalo DentalBuffalo Dental Manufacturing Co., Inc.KMT2026-04-10
00889813067857Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067864Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067871Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067888Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067895Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067901Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067918Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067925Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067932Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067949Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067956Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067854Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067861Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067878Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067885Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067892Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067908Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067915Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067922Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067939Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067946Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067953Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00766054003007Turbo-CRESSENTIAL DENTAL SYSTEMS, INC.KMT2025-04-04
D956FLTRAY25Fluoride Gel Tray 25-pkD.S.I DENTAL SOLUTIONS LTDKMT2024-07-01
00810339031282SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031428SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031480SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031299SAFE DENTBGSS Company Inc.KMT2024-05-01