FDA.reportPublic FDA data

ISSA 4

Primary DI
07350120792990
Brand
ISSA 4
Company
Foreo AB
Model
Fuchsia
Device description
ISSA 4 is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Published
2025-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
07350120792990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350120792990073501207929907350120792990

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
352394143
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640260120600FAQ LED PanelBlack2026-03-02
07640260120617FAQ Dual LED PanelBlack2026-03-02
07350120791733BEAR 2 eyes & lipsLavender2024-03-07
07350120791740BEAR 2 eyes & lipsArctic Blue2024-03-07
07350120791795BEAR 2Fuchsia2024-03-07
07350120791801BEAR 2Lavender2024-03-07
07350120791818BEAR 2Evergreen2024-03-07
07350120791825BEAR 2 goLavender2024-03-07
07350120791849BEAR 2 goPistachio2024-03-07
07350120791757ESPADA 2 PlusLavender2024-02-20
07350120791764ESPADA 2 PlusPistachio2024-02-20
07640260120662FAQ 202 PlusBlack2025-07-15
07640260120044FAQ 102Pink Ruby2024-07-18
07640260120051FAQ 103Blak Diamond2024-07-18
07640260120112FAQ 102Topaz2024-07-18
07640260120037FAQ 101Amethyst2024-03-01
07350120792976ISSA 4 PlusBlack2025-05-27
07350120792983ISSA 4 PlusLavender2025-05-27
07350120793003ISSA 4Pearl Pink2025-05-27
07350120793010ISSA 4Arctic Blue2025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938320799899SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799905SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799912SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799929SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799936SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799943SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799950SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799967SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799981SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799998SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
05060640673731OrdoORDOCLUB LTDJEQ2026-09-22
05060640673748OrdoORDOCLUB LTDJEQ2026-09-22
05060640674097OrdoORDOCLUB LTDJEQ2026-09-22
05060640674141OrdoORDOCLUB LTDJEQ2026-09-22
05060640674486OrdoORDOCLUB LTDJEQ2026-09-22
00072239332290Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
00072239332511Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
00072239332528Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
05060640673717OrdoORDOCLUB LTDJEQ2026-05-29
05060640673830OrdoORDOCLUB LTDJEQ2026-05-29
05060640673953OrdoORDOCLUB LTDJEQ2026-05-29
05060640673960OrdoORDOCLUB LTDJEQ2026-05-29
05060640673991OrdoORDOCLUB LTDJEQ2026-05-29
05060640674004OrdoORDOCLUB LTDJEQ2026-05-29
05060640674011OrdoORDOCLUB LTDJEQ2026-05-29
05060640674035OrdoORDOCLUB LTDJEQ2026-05-29
00073950323734WaterPik Sensonic Toothbrush Brush Heads (3pk)WATER PIK, INC.JEQ2026-03-03
00197344175874MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00197344175881MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00194346288038EQUATEWAL-MART STORES, INC.JEQ2024-11-15