FDA Registration
Active
🇺🇸 United States
implant, endosseous, root-form
Reg #: 3016784205
·
FEI: 3016784205
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEWTON IMPLANT SYSTEMS
- Registration Number
- 3016784205
- FEI Number
- 3016784205
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 440 S. Melrose dr Suite 202
- City
- Vista
- State
- CA
- ZIP
- 92081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221866
Owner / Operator
- Firm Name
- newton implant systems
- Operator Number
- 10085841
- Address
- 6727 Flanders dr #230
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Pedro Yang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2024-03-12 |
Proprietary Names
implant, endosseous, root-form
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility