FDA Registration
Active
🇺🇸 United States
Lucitone Digital Print for Primeprint
Reg #: 2424472
·
FEI: 3002088145
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- DENTSPLY LLC
- Registration Number
- 2424472
- FEI Number
- 3002088145
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1301 SMILE WAY
- City
- York
- State
- PA
- ZIP
- 17404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231578
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 |
|---|---|---|---|---|---|
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2023-11-03 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2023-11-03 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2023-11-03 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2023-11-03 |
Proprietary Names
Lucitone Digital Print for Primeprint
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility