FDA.reportPublic FDA data

DENTEK CMPLT CLEAN BK 75CT FLS PICK 72

Primary DI
00047701002155
Brand
DENTEK CMPLT CLEAN BK 75CT FLS PICK 72
Company
DenTek Oral Care, Inc.
Model
10047701002152
Device description
DENTEK COMPLETE CLEAN BACK 75CT FLOSS PICK 72
Published
2022-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00047701002155PrimaryGS10
30047701002156Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00047701002155000477010021550477010021550047701002155
3004770100215630047701002156

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.

Regulatory Flags#

DUNS number
153818646
Device count
75
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00047701001813Dentek100477010018102024-06-19
00047701000403Dentek10047701000400A2020-07-14
00047701000410Dentek100477010004172020-12-08
00047701000717DENTEK CROSS FLOSSER 75CT FLS PICK 36200477010007112022-10-21
00047701000816DENTEK ADVANCED TRIPLE CLEAN 90CT FLOSS PICK 36100477010008132022-10-20
00047701000847DENTEK FUN 90CT FUN FLOSSER 36200477010008412022-10-21
00047701000922DENTEK CMF CLEAN 90CT FLOSS PICK 72100477010009292022-10-21
00047701001127DENTEK EARTH FRNDLY TRPL 60CT PICK 30100477010011242022-10-21
00047701001134DENTEK EASY BRUSH STD 10CT IDBR 36100477010011312022-10-07
00047701001202Dentek00038904806A2020-10-06
00047701001516Dentek00015101203I22020-07-14
00047701001745DNTK FRSH BREATH 90CT FLS PICK 36200477010017492022-10-21
00047701001752Dentek100477010017592022-10-05
00047701001905DENTEK ADVANCED TRIPLE CLEAN 150CT FLOSS PICK 30500477010019002022-10-20
00047701001950DENTEK CMF CLEAN 150CT FLOSS PICK 30200477010019542022-10-21
00047701002032DENTEK EASY BRUSH STD 16CT IDBR 36100477010020392022-10-11
00047701002100DENTEK FUN 75CT FLOSSER 36100477010021072022-10-21
00047701002247DENTEK SLIM BRUSH 32CT IDBR 36100477010025412022-10-11
00047701002407DENTEK DEEP CLEAN 100CT IDBR 24100477010024042022-10-11
00047701002568DENTEK FUN 40CT FLOSSER 72100477010025652022-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00070942008822GUM® Expanding FlossSUNSTAR AMERICAS, INC.JES2026-05-01
00070942008952GUM® Professional Clean FlossSUNSTAR AMERICAS, INC.JES2026-04-30
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERSSUNSTAR AMERICAS, INC.JES2025-11-04
10371347019732Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
10371347019749Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-06-25
10810063755567Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756182Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756199Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756656Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756663Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10304040189853Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189860Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189877Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189884Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
00032251933462Family WellnessFamily Dollar StoresJES2024-05-03
00032251933486Family WellnessFamily Dollar StoresJES2024-05-03
00032251933493Family WellnessFamily Dollar StoresJES2024-05-03
00032251933523Family WellnessFamily Dollar StoresJES2024-05-03
00032251933479Family WellnessFamily Dollar StoresJES2024-04-09
00032251933509Family WellnessFamily Dollar StoresJES2024-04-09
00070942007153GUM®SUNSTAR AMERICAS, INC.JES2024-04-05
00070942007177GUM®SUNSTAR AMERICAS, INC.JES2024-04-05
00070942006590GUM®SUNSTAR AMERICAS, INC.JES2024-03-15
00070942006552GUM®SUNSTAR AMERICAS, INC.JES2024-03-14
00070942006576GUM®SUNSTAR AMERICAS, INC.JES2024-03-13
00070942006514GUM®SUNSTAR AMERICAS, INC.JES2024-03-12
00070942006613GUM®SUNSTAR AMERICAS, INC.JES2024-03-12
00070942006606GUM®SUNSTAR AMERICAS, INC.JES2024-03-07
00070942006583GUM®SUNSTAR AMERICAS, INC.JES2024-03-05