FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
10843471178215
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
760-126
Catalog number
760-126
Device description
Anatomical Molar Bands, Upper Left 1St & 2Nd Molars, Size 26
Published
2022-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843471178215PackageGS11In Commercial Distribution
00843471178218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347117821510843471178215
00843471178218008434711782188434711782180843471178218

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

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
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00840456206225JMUJMU DENTAL, INCECM2026-06-25
00840456206232JMUJMU DENTAL, INCECM2026-06-25
00190707133207Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707134341Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707140021Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707140366Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707141387Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707141516Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
08033707035015LEONE SPALEONE SPAECM2020-11-10
08033707035022LEONE SPALEONE SPAECM2020-11-10
08033707035039LEONE SPALEONE SPAECM2020-11-10
08033707035046LEONE SPALEONE SPAECM2020-11-10
08033707035053LEONE SPALEONE SPAECM2020-11-10
08033707035060LEONE SPALEONE SPAECM2020-11-10
08033707035077LEONE SPALEONE SPAECM2020-11-10
08033707035084LEONE SPALEONE SPAECM2020-11-10
08033707035091LEONE SPALEONE SPAECM2020-11-10
08033707035107LEONE SPALEONE SPAECM2020-11-10
08033707035114LEONE SPALEONE SPAECM2020-11-10
08033707035121LEONE SPALEONE SPAECM2020-11-10
08033707035138LEONE SPALEONE SPAECM2020-11-10
08033707035145LEONE SPALEONE SPAECM2020-11-10
08033707035152LEONE SPALEONE SPAECM2020-11-10
08033707035169LEONE SPALEONE SPAECM2020-11-10
08033707035176LEONE SPALEONE SPAECM2020-11-10
08033707035183LEONE SPALEONE SPAECM2020-11-10
08033707035190LEONE SPALEONE SPAECM2020-11-10
08033707035206LEONE SPALEONE SPAECM2020-11-10
08033707035213LEONE SPALEONE SPAECM2020-11-10
08033707035220LEONE SPALEONE SPAECM2020-11-10