FDA Registration
Active
🇺🇸 United States
Oral-B 5% Sodium Fluoride Varnish
Reg #: 1941138
·
FEI: 1941138
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- YOUNG DENTAL MANUFACTURING CO 1, LLC.
- Registration Number
- 1941138
- FEI Number
- 1941138
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 13705 Shoreline Ct E
- City
- EARTH CITY
- State
- MO
- ZIP
- 63045
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153334
Owner / Operator
- Firm Name
- Young Innovations Inc
- Operator Number
- 9031933
- Address
- 2260 Wendt street
- City
- Algonquin
- State
- IL
- Postal Code
- 60102
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2016-09-13 |
Proprietary Names
Oral-B 5% Sodium Fluoride Varnish
Varnish Pen 5% Sodium Fluoride
Zooby Fluoride Varnish
Private Labeled 5% Sodium Fluoride Varnish
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device