FDA.reportPublic FDA data

Equaline

Primary DI
00041163498617
Brand
Equaline
Company
SUPERVALU INC.
Model
ULE
Device description
Polaris II Power Toothbrush medium
Published
2020-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JEQToothbrush, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEQToothbrush, PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041163498614PackageGS136In Commercial Distribution
00041163498617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004116349861410041163498614
00041163498617000411634986170411634986170041163498617

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric toothbrushAn electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. This is a reusable device.

Regulatory Flags#

DUNS number
006961411
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041163500648Equaline0411635006482020-05-29
00041163498174EqualineALB4145ALB41452025-10-09
00041163250925Equaline7W926ELC22022-10-11
00041163503885EqualineKD-20502023-09-05
20041163503889EqualineKD-20502023-09-05
10041163250922Equaline7W926ELC22022-10-11
00041163263352Equaline TamponsBSVAR402016-09-20
00041163263369Equaline TamponsBSVAS402016-09-20
00041163263383Equaline TamponsBSVAC402016-09-20
00041163444164Equaline TamponsBSVGC362016-09-20
00041163471559Equaline TamponsBSVGS182016-09-20
00041163497306Equaline TamponsBSVUR182016-09-20
00041163497313Equaline TamponsBSVUS182016-09-20
00041163497344Equaline TamponsBSVGS362016-09-20
00041163497368Equaline TamponsBSVGR362016-09-20
00041163497375Equaline TamponsBSVGR182016-09-20
00041163499133Equaline TamponsBSVXR182017-05-02
00041163499140Equaline TamponsBSVXS182017-05-02
00041163499157Equaline TamponsBSVXC182017-05-02
00041163450240Equaline0411634502402020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950323734WaterPik Sensonic Toothbrush Brush Heads (3pk)WATER PIK, INC.JEQ2026-03-03
00197344175874MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00197344175881MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00817277021054UsmileGuangzhou Stars Pulse Co., Ltd.JEQ2025-10-05
00194346288038EQUATEWAL-MART STORES, INC.JEQ2024-11-15
00032251933578Family WellnessFamily Dollar StoresJEQ2024-04-09
00073950330046Waterpik Sensonic Complete CareWATER PIK, INC.JEQ2024-02-13
10810063755321OralPro Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
10810063755345OralPro Ultra Sensitive Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
10810063755352SonicPro Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
10810063755376SonicPro Compact Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
10810063755383SonicPro Ultra Sensitive Electric Toothbrush Replacement HeadSAFCO DENTAL SUPPLY CO.JEQ2023-08-14
00194346119691Equate Essential Clean Replacement Toothbrush Brush HeadsWAL-MART STORES, INC.JEQ2023-07-10
00194346119707Equate Advanced Clean Replacement Toothbrush Brush HeadsWAL-MART STORES, INC.JEQ2023-07-10
00723896001936Smilegoods Sonic Toothbrush BlackPRACTICON, INC.JEQ2023-06-09
00723896018729Smilegoods Sonic Toothbrush White PRACTICON, INC.JEQ2023-06-09
00723896018743Smilegoods Sonic Toothbrush PinkPRACTICON, INC.JEQ2023-06-09
00073950324779Waterpik Cordless Pearl Water Flosser and Sensonic ToothbrushWATER PIK, INC.JEQ2023-06-02
00810051084313Gurunanda Ultimate Oral Care ComboGurunanda, LLCJEQ2023-05-31
00810051083637Sonic Vibration Expert Clean Toothbrush - 2 PackGurunanda, LLCJEQ2023-04-27
00073950314596Waterpik Complete Care SensonicWATER PIK, INC.JEQ2023-04-13
00073950314572Waterpik Complete Care SensonicWATER PIK, INC.JEQ2023-04-12
00070942122542GUM®SUNSTAR AMERICAS, INC.JEQ2023-02-28
00070942122559GUM®SUNSTAR AMERICAS, INC.JEQ2023-02-28
00817169023067Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEQ2023-01-11
00817169023074Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEQ2023-01-11
00817169023081Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEQ2023-01-11
00075020072009Philips SonicarePHILIPS ORAL HEALTHCARE, LLCJEQ2022-11-30
00075020072023Philips SonicarePHILIPS ORAL HEALTHCARE, LLCJEQ2022-11-30
00075020072207Philips SonicarePHILIPS ORAL HEALTHCARE, LLCJEQ2022-11-30