FDA Registration
Active
🇺🇸 United States
DENTSPLY NORTH AMERICA LLC
Reg #: 3006186796
·
FEI: 3006186796
·
Expires 2026
Products
10
Proprietary Names
7
Establishment Types
1
Classifications
10
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Registration Details
- Registration Name
- DENTSPLY NORTH AMERICA LLC
- Registration Number
- 3006186796
- FEI Number
- 3006186796
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1800 Cloister Drive
- City
- Lancaster
- State
- PA
- ZIP
- 17601
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191865
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 |
|---|---|---|---|---|---|
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2005-12-28 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 1996-08-21 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2006-06-12 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2019-11-20 |
| Caries Detector, Laser Light, Transmission | NTK | Class 2 | Dental | No | 2019-11-20 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 1996-08-21 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 1992-08-24 |
| Cleaner, Denture, Mechanical | JER | Class 1 | Dental | No | 2003-10-02 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 1998-09-08 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 1977-12-15 |
Proprietary Names
Drills
GATES
LARGO
Flex-View Interproximal Strips
Interproximal Serrated Strips
Caulk Post & Core Kit
Paper Points
Establishment Types
Repack or Relabel Medical Device