FDA.reportPublic FDA data

Plak Smacker

Primary DI
10843471152642
Brand
Plak Smacker
Company
Young Innovations, Inc.
Model
400044
Catalog number
400044
Device description
Ortho Water Bottle Kit (BPA Free)
Published
2024-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JESFloss, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JESFloss, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843471152642PackageGS124In Commercial Distribution
20843471152649PackageGS11In Commercial Distribution
00843471152645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347115264210843471152642
2084347115264920843471152649
00843471152645008434711526458434711526450843471152645

GMDN Terms#

Term, Definition table
TermDefinition
Dental flossA string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
004193103
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
10840326426200Young Specialties2000-02-102000-02-102026-01-26
10840326426217Young Specialties2000-03-102000-03-102026-01-26
10840326426224Young Specialties2000-04-102000-04-102026-01-26
10840326426231Young Specialties2000-05-102000-05-102026-01-26
10840326426248Young Specialties2000-06-102000-06-102026-01-26
10840326426255Young Specialties2000-07-102000-07-102026-01-26
10840326426262Young Specialties2000-08-102000-08-102026-01-26
10840326426279Young Specialties2000-09-102000-09-102026-01-26
10840326426286Young Specialties2000-10-102000-10-102026-01-26
10840326426293Young Specialties2000-15-102000-15-102026-01-26
00840326426302Young Specialties2000-16-102000-16-102026-01-26
10840326426316Young Specialties2000-17-102000-17-102026-01-26
10840326426323Young Specialties2000-18-102000-18-102026-01-26
10840326426330Young Specialties2000-19-102000-19-102026-01-26
10840326426347Young Specialties2000-20-102000-20-102026-01-26
10840326426354Young Specialties2000-21-102000-21-102026-01-26
10840326426361Young Specialties2000-22-102000-22-102026-01-26
10840326426378Young Specialties2000-23-102000-23-102026-01-26
10840326426385Young Specialties2000-24-102000-24-102026-01-26
10840326426392Young Specialties2000-25-102000-25-102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975843620002HIT PROMOTIONAL PRODUCTS, INC.YUYAO NEW POWER PROMOTION INDUSTRIAL CO., LTDJES2026-05-26
16931718175647HIT PROMOTIONAL PRODUCTS, INCNew Phenix Home Products Manufactory Co., Ltd.JES2026-03-03
008171690226333D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJES2025-12-16
16931718175616HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2025-08-05
D83230000EXPANDII FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323000B0EXPANDII FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323000T0EXPANDII FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D83231000FINE FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323100B0FINE FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323100T0FINE FLOSSIIPLASDENT CORPORATIONJES2025-06-02
16931718175609HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2025-05-07
10810051081784GURUNANDA DUAL-SLICKER FLOSS PICKGurunanda, LLCJES2025-05-06
10810051083412GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGurunanda, LLCJES2025-05-06
00810051085532GURUNANDA EXPANDABLE FLOSSGurunanda, LLCJES2025-05-06
06973026120288MeizhikangMeizhikang Technology (Shenzhen) Co., Ltd.JES2025-04-21
16931718175586HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2025-04-18
00860009239623INNOVATION LINEInnovation SpecialtiesJES2025-04-15
00860009239630INNOVATION LINEInnovation SpecialtiesJES2025-04-15
20810063755564Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756189Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756196Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756653Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756660Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
00359883005696Re-Cord™ Knitted Retraction Cord #000DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005702Re-Cord™ Knitted Retraction Cord #00DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005719Re-Cord™ Knitted Retraction Cord #0DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005726Re-Cord™ Knitted Retraction Cord #1DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005733Re-Cord™ Knitted Retraction Cord #2DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005740Re-Cord™ Knitted Retraction Cord #3DEN-MAT HOLDINGS, LLCJES2025-03-12
00304040189818Henry ScheinHENRY SCHEIN, INC.JES2025-01-30