ISSA™
Basic Information
- Brand Name
- ISSA™
- Primary DI
- 07350071073308
- Version / Model
- MINT
- Company Name
- Foreo AB
- Labeler DUNS
- 352394143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-26
- Public Version
- 1
- Public Version Date
- 2022-06-03
- Public Version Status
- New
- Public Device Record Key
- ec1f8876-c3c6-4765-a449-8015d376481f
Device Description
The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA channels high-intensity pulsation through its unique brush head to clean teeth gently and effectively, utilizing silicone's natural friction properties to remove plaque while offering a comfortable gum massage for a cleaner, healthier mouth. Its ultra-hygienic, soft silicone bristles are gentle on tooth enamel and gums, while its sleek, ergonomic design offers 3D flexibility, reaching every crevice in the mouth. Easy to clean and sterilize, ISSA is quick-drying, nonporous and resistant to bacteria buildup, making it far more hygienic than nylon-bristled toothbrushes. Easy to use with a single-button interface and eight adjustable speeds, ISSA reminds you to switch quadrants every 30 seconds and signals when your two-minute brushing routine is over. The 100% waterproof device is travel friendly, requiring no charging dock—a single full charge lasts for 365 uses. The brush head only needs replacement once per year.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JEQ | Toothbrush, Powered | Dental | 872.6865 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43090 | Basic electric toothbrush | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350071073308 | GS1 |