FDA.reportPublic FDA data

Plak Smacker

Primary DI
10840326422431
Brand
Plak Smacker
Company
Young Innovations, Inc.
Model
545-06533
Catalog number
545-06533
Device description
Elastic Power Chain, Continuous, 15', Orange
Published
2024-01-24
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
false

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
10840326422431PackageGS11In Commercial Distribution
00840326422434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032642243110840326422431
00840326422434008403264224348403264224340840326422434

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic inter-bracket elastic chainA non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07908470707135ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 1/4 - SILMETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908470707142ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 3/16 - SILMETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908470707159ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 1/4 - SILMETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908470707166ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 3/16 - SILMETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611205964ORTHOMETRIC ELASTIC STICK LIGATURE - ORANGEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611207944KIT ELASTOMERIC - STICK LIGATURES - 23 COLORSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611207951KIT ELASTOMERIC - ELASTIC CHAIN 1,5M - MEDIUM - 23 COLORSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611207968KIT ELASTOMERIC - MODULAR LIGATURE 22 TIES - 10 COLORSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210654ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - CARIBBEAN BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210715ORTHOMETRIC ELASTIC STICK LIGATURE - CORALORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210722ORTHOMETRIC ELASTIC STICK LIGATURE - MARSALAORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210739ORTHOMETRIC ELASTIC STICK LIGATURE - CARIBBEAN BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210746ORTHOMETRIC ELASTIC STICK LIGATURE - NEON GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611211309KIT ELASTOMERIC - MODULAR LIGATURES 22 TIES - 27 COLORSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611212382ORTHOFLEXY ELASTIC CHAIN 4.5M - LONG (.166") -METALIC BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217288ORTHOFLEXY ELASTIC CHAIN 4.5M - LONG (.166") - CRYSTAL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217295ORTHOFLEXY ELASTIC CHAIN 4.5M - LONG (.166") - CRYSTAL REDORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217301ORTHOFLEXY ELASTIC CHAIN 4.5M - LONG (.166") - PEARL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217318ORTHOFLEXY ELASTIC CHAIN 4.5M - CLOSED (.113") - CRYSTAL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217325ORTHOFLEXY ELASTIC CHAIN 4.5M - CLOSED (.113") - PEARL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217332ORTHOFLEXY ELASTIC CHAIN 4.5M - CLOSED (.113") - CRYSTAL REDORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217349ORTHOFLEXY ELASTIC CHAIN 4.5M - SHORT (.136") - CRYSTAL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217356ORTHOFLEXY ELASTIC CHAIN 4.5M - SHORT (.136") - CRYSTAL REDORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217363ORTHOFLEXY ELASTIC CHAIN 4.5M - SHORT (.136") - PEARL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
D771349300101Dental CityICP, INC.ECI2026-05-27
D771349300201Dental CityICP, INC.ECI2026-05-27
D771349300301Dental CityICP, INC.ECI2026-05-27
D771349300401Dental CityICP, INC.ECI2026-05-27
D771349300501Dental CityICP, INC.ECI2026-05-27
D771349300601Dental CityICP, INC.ECI2026-05-27