FDA.reportPublic FDA data

Dentek

Primary DI
00047701001813
Brand
Dentek
Company
DenTek Oral Care, Inc.
Model
10047701001810
Device description
DNTK GUM HEALTH CLEANING KIT 36
Published
2024-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELAInstrument, Hand, Calculus Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELAInstrument, Hand, Calculus RemovalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10047701001810PackageGS11In Commercial Distribution
00047701001813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004770100181010047701001810
00047701001813000477010018130477010018130047701001813

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
8779255374xx@xx.com

Regulatory Flags#

DUNS number
153818646
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
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
00047701002155DENTEK CMPLT CLEAN BK 75CT FLS PICK 72100477010021522022-10-21
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
00810132809446House Brand DentistryFrontier Dental Supply IncELA2026-02-10
00810132809439House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00810132809453House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00810132809460House Brand DentistryFrontier Dental Supply IncELA2025-05-14
ESAM1820001STOMA®Storz am Mark GmbHELA2020-08-27
ESAM1825001STOMA®Storz am Mark GmbHELA2020-08-27
ESAM1826001STOMA®Storz am Mark GmbHELA2020-08-27
00840018624139NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625068NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625235NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625242NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625259NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625266NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625273NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625280NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018616851NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616868NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616875NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616882NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616899NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616905NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616912NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616929NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616936NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616943NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616950NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616967NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616974NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616981NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616998NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12