FDA Registration
Active
🇺🇸 United States
Elastic Mandibular Advancement (EMA) appliance
Reg #: 3014680794
·
FEI: 3014680794
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- JOHNS DENTAL LABORATORY
- Registration Number
- 3014680794
- FEI Number
- 3014680794
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 423 S 13th Street
- City
- Terre Haute
- State
- IN
- ZIP
- 47807
- Country
- US
Regulatory Submissions
- 510(k) Number
- K971794
Owner / Operator
- Firm Name
- Johns Dental Lab
- Operator Number
- 10058109
- Address
- 423 S 13th Street
- City
- Terre Haute
- State
- IN
- Postal Code
- 47807
- Country
- US
- Correspondent
- Dawn Atkinson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2024-11-07 |
Proprietary Names
Elastic Mandibular Advancement (EMA) appliance
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)