FDA UDI
In Commercial Distribution
🇺🇸 United States
Smilegoods Sonic Toothbrush White
DI: 00723896018729
·
Model: 7155010 WHI
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Smilegoods Sonic Toothbrush White
- Primary DI
- 00723896018729
- Version / Model
- 7155010 WHI
- Catalog Number
- 7155010 WHI
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-09
- Public Version
- 1
- Public Version Date
- 2023-06-19
- Public Version Status
- New
- Public Device Record Key
- 17c07b16-031e-4371-993e-6c41edadfd91
Device Description
Rechargable electric toothbrush with high density bristles. 1 Sonic handle, 2 brush heads, and charging base and cable. White color
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| 38581 | Ionic electric toothbrush | A battery-powered instrument designed to brush clean the teeth and gums. It typically consists of a proximal handle and distal head to which is attached two or more rows of bristles (e.g., nylon) grouped in separate tufts, in rows, or evenly distributed; the head includes a light-activated semiconductor [e.g., a titanium (Ti) rod] that releases negative ions intended to disintegrate dental plaque. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing and is used with toothpaste; it is normally available [non-prescription] over-the-counter (OTC). The toothbrush head may be exchangeable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896018736 | GS1 | case | 36 | In Commercial Distribution | |
| Primary | 00723896018729 | GS1 |