FDA Registration
Active
🇺🇸 United States
Dentsply Sirona Orthodontics Inc.
Reg #: 1649995
·
FEI: 3001947560
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Dentsply Sirona Orthodontics Inc.
- Registration Number
- 1649995
- FEI Number
- 3001947560
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1125 E Campbell Rd Ste 100
- City
- RICHARDSON
- State
- TX
- ZIP
- 75081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002620
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 |
|---|---|---|---|---|---|
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2022-12-13 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2019-12-16 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 1992-08-12 |
| General Purpose Dental Tray | OFX | Class 1 | Dental | No | 2022-11-04 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2019-12-16 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2005-03-01 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2026-03-12 |
Proprietary Names
SureSmile Advanced Software v 7.6
SureSmile Ortho Software v 7.6
SureSmile Aligner Software v 7.6
SureSmile Wires
SureSmile Aligner Transfer Tray
SureSmile Aligner
SureSmile Orthodontic Software
SureSmile Advanced Software
SureSmile Aligner Software
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device