FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
00840326406304
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
400042
Catalog number
400042
Device description
Medium Foam Fluoride Tray - Yellow
Published
2022-11-02
Public version status
New
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
EHYTRAY, IMPRESSION, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840326406301PackageGS150In Commercial Distribution
00840326406304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032640630110840326406301
00840326406304008403264063048403264063040840326406304

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17
00840326423875Astek19027190272025-03-17
00840326423882Astek19028190282025-03-17
00843471150061Astek19000190002022-10-18
00843471150078Astek19005190052022-10-18
00843471150085Astek19001190012022-10-18
00843471150092Astek19006190062022-10-18
00840326426586Plak Smacker2000622026-04-20
00840326426593Plak Smacker2000632026-04-20
00840326426609Plak Smacker2000642026-04-20
00840326426616Plak Smacker2000652026-04-20
00840326426623Plak Smacker2000662026-04-20
00840326426203Young Specialties2000-02-102000-02-102026-01-26
00840326426210Young Specialties2000-03-102000-03-102026-01-26
00840326426227Young Specialties2000-04-102000-04-102026-01-26
00840326426234Young Specialties2000-05-102000-05-102026-01-26
00840326426241Young Specialties2000-06-102000-06-102026-01-26
00840326426258Young Specialties2000-07-102000-07-102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D1254104Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254114Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254124Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254134Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254144Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254154Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254164Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254174Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254184Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254194Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254204Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254304Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
08961104622654Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08961104622661Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08906139322087Taglus Impression TrayLAXMI DENTAL LIMITEDEHY2026-01-09
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00190707110871DuraLock®Ortho Organizers, Inc.EHY2025-09-25
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00190707110895DuraLock®Ortho Organizers, Inc.EHY2025-09-25
07615208301304Centric TrayIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHY2025-03-20