FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
00840326403051
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
299-400
Catalog number
299-400
Device description
DISC GUARD
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EEJGUARD, DISK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEJGuard, DiskDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840326403058PackageGS11In Commercial Distribution
00840326403051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032640305810840326403058
00840326403051008403264030518403264030510840326403051

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk guardA dental device intended to be fitted around an abrasive disk when rotating at high-speed to protect tissues not intended to come in contact with the abrasive disk. It is typically made of metal. This is a reusable device.

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
true
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
10840326403058The Orthodontic StoreYoung Innovations, Inc.EEJ2022-11-24
J01174206000N.A.DENTAURUM GmbH & Co.KGEEJ2018-12-06
J011074000000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074001000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074100000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074203000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074101000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074200000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074201000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15