FDA.reportPublic FDA data

Plak Smacker

Primary DI
00840326422168
Brand
Plak Smacker
Company
Young Innovations, Inc.
Model
253-02104
Catalog number
253-02104
Device description
Ten Ties, Black (1,000 ct)
Published
2024-01-24
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
ECIBand, elastic, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840326422165PackageGS11000In Commercial Distribution
00840326422168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032642216510840326422165
00840326422168008403264221688403264221680840326422168

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwire/bracket ligatureA device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800) 275-0020support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
07908611213051ORTHOMETRIC MODULAR LIGATURE 22 TIES - LIME GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611213105ORTHOMETRIC MODULAR LIGATURE 22 TIES - NEON YELLOWORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611213754ORTHOMETRIC MODULAR LIGATURE 22 TIES - GREEN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611213891ORTHOMETRIC MODULAR LIGATURE 22 TIES - EMERALD GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215031ORTHOMETRIC ELASTIC STICK LIGATURE - METALIC NAVYORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215048ORTHOMETRIC ELASTIC STICK LIGATURE - ROYAL BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215055ORTHOMETRIC ELASTIC STICK LIGATURE - METALIC BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215062ORTHOMETRIC ELASTIC STICK LIGATURE - OCEAN BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215079ORTHOMETRIC ELASTIC STICK LIGATURE - TURQUOISEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611210333ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-07
07908611211163PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-07
07908611211170PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-07
07908611210319KIT ICERAM-P ROTH 0.022 + 1 PAIR OF ESTHETIC ARCHWIRE + 1 MODULAR PEARL BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-03
07908470704738KIT ADVANCED METAL BRACKETS ROTH 0.022 10 SETS + ARCHES + ELASTICORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-02
07908470704776KIT ADVANCED METAL BRACKETS MBT 0.022 10 SETS + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-02
07908470704912KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-02
10190886033852NAG & H Wire Company, Inc.ECI2025-03-26
10190886033869NAG & H Wire Company, Inc.ECI2025-03-26
10190886033876NAG & H Wire Company, Inc.ECI2025-03-26
10190886033883NAG & H Wire Company, Inc.ECI2025-03-26
10190886101377NAG & H Wire Company, Inc.ECI2025-03-26
10190886101384NAG & H Wire Company, Inc.ECI2025-03-26
10190886101391NAG & H Wire Company, Inc.ECI2025-03-26
10190886101407NAG & H Wire Company, Inc.ECI2025-03-26
10190886101414NAG & H Wire Company, Inc.ECI2025-03-26
10190886101421NAG & H Wire Company, Inc.ECI2025-03-26
10190886101438NAG & H Wire Company, Inc.ECI2025-03-26
10190886101445NAG & H Wire Company, Inc.ECI2025-03-26
10190886101452NAG & H Wire Company, Inc.ECI2025-03-26
10190886101469NAG & H Wire Company, Inc.ECI2025-03-26