FDA UDI
In Commercial Distribution
🇺🇸 United States
Silk'n
DI: 17290112451672
·
Model: ToothWave US
·
HOME SKINOVATIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Silk'n
- Primary DI
- 17290112451672
- Version / Model
- ToothWave US
- Catalog Number
- 7290112451675
- Company Name
- HOME SKINOVATIONS LTD
- Labeler DUNS
- 514891048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-19
- Public Version
- 1
- Public Version Date
- 2021-05-27
- Public Version Status
- New
- Public Device Record Key
- 222f7018-2561-4033-b14a-ccddabb64f1f
Device Description
ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| QMJ | Powered Radiofrequency Toothbrush | Dental | 872.6866 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65482 | Radio-frequency toothbrush | An electrically-powered toothbrush, that additionally applies to dentition a radio-frequency (RF) alternating current, designed to be used to brush clean teeth and gums (i.e., remove plaque, tartar, stains). It consists of a proximal handle, and an exchangeable distal head with rows of bristles (e.g., nylon) and electrodes to generate the RF current into toothpaste and along dentition. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07290112451675 | GS1 | ||||
| Primary | 17290112451672 | GS1 | ||||
| Package | 27290112451679 | GS1 | Box | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-877-367-4556
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN190039 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal