FDA.reportPublic FDA data

DENTEK SLIM BRUSH 32CT IDBR 36

Primary DI
00047701002247
Brand
DENTEK SLIM BRUSH 32CT IDBR 36
Company
DenTek Oral Care, Inc.
Model
10047701002541
Device description
DENTEK SLIM BRUSH 32CT IDBR 36
Published
2022-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFWToothbrush, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10047701002541PackageGS132In Commercial Distribution
00047701002247PrimaryGS10
30047701002248Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004770100254110047701002541
00047701002247000477010022470477010022470047701002247
3004770100224830047701002248

GMDN Terms#

Term, Definition table
TermDefinition
Basic manual toothbrushAn instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-877-925-5374xx@xx.com

Regulatory Flags#

DUNS number
153818646
Device count
32
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
00047701002155DENTEK CMPLT CLEAN BK 75CT FLS PICK 72100477010021522022-10-21
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
10889483565599BALLARD™SUNMED, LLCEFW2026-01-12
00070942007368GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942007412GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942008099GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10304040192471Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyEFW2025-06-25
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
00070942006378GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
00070942008105GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
00070942008112GUM Technique Deep CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
10810063756243KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756250Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756267Esprit Ultra Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756274Whisper Tech Ultra-Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756281Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756403Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756434KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756588Jr Series Comfort Grip ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756595Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756175Euro Tech Compact Sensitive ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756205Endeavor ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756212Vital Fresh ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756229Aspire Compact ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756236PlaquePRO Interdental Proxy BrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756397Polisher Compact ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756533Soft Flex ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756540Glisten Junior ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756557Curve Contour ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756564Silhouette ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18