FDA Registration
Active
🇺🇸 United States
K080633
Reg #: 3001617766
·
FEI: 3001617766
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Registration Number
- 3001617766
- FEI Number
- 3001617766
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3050 East Hillcrest Drive
- City
- Thousand Oaks
- State
- CA
- ZIP
- 91362
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080633
Owner / Operator
- Firm Name
- Implant Direct
- Operator Number
- 9069060
- Address
- 3050 East Hillcrest Drive, --
- City
- Thousand Oaks
- State
- CA
- Postal Code
- 91362
- Country
- US
- Correspondent
- Frank Ray
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2008-08-06 |
Proprietary Names
K080633
ScrewIndirect Dental Implants
Establishment Types
Manufacture Medical Device