FDA UDI
In Commercial Distribution
🇺🇸 United States
PerioSciences LED Electric Toothbrush
DI: 00353238006109
·
Model: 10610
·
Perio Sciences, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PerioSciences LED Electric Toothbrush
- Primary DI
- 00353238006109
- Version / Model
- 10610
- Company Name
- Perio Sciences, LLC
- Labeler DUNS
- 961798605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-08
- Public Version
- 1
- Public Version Date
- 2024-02-16
- Public Version Status
- New
- Public Device Record Key
- 254e1459-25ab-41a6-af6a-489dfc982d8e
Device Description
An electrically powered device designed to be used by a patient-consumer to brush clean their teeth and gums (i.e., to remove plaque, tartar and stains). It comprises a proximal handle and an exchangeable distal head with rows of bristles group in separate tufts. The device provides automated vibratory bristle movement intended to augment brushing. The brush also provides a blue and red LED light to help clean the teeth, stimulate soft tissue, and promote overall oral health. The brush is typically used with toothpaste.
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 | 00353238006109 | GS1 |