FDA Registration
Active
🇺🇸 United States
SureSmile Aligner Transfer Tray
Reg #: 1649995
·
FEI: 3001947560
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Dentsply Sirona Orthodontics Inc.
- Registration Number
- 1649995
- FEI Number
- 3001947560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1125 E. Campbell Rd, SUITE 100
- City
- RICHARDSON
- State
- TX
- ZIP
- 75081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171860
Owner / Operator
- Firm Name
- DENTSPLY SIRONA INC
- Operator Number
- 2511302
- Address
- 221 WEST PHILADELPHIA ST., SUITE 60W
- City
- York
- State
- PA
- Postal Code
- 17401
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2019-12-16 |
Proprietary Names
SureSmile Aligner Transfer Tray
SureSmile Aligner
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility