Data / Medical devices / United States / Dentsply North America LLC
Dentsply North America LLC: FDA-registered device maker in Lancaster, PA, United States, 1 510(k) clearance
Dentsply North America LLC is registered with the FDA (registration 3006186796) in Lancaster, PA, United States. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 20, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006186796
- Address
- 1800 Cloister Drive, Lancaster, PA, United States, 17601
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Repackager or relabeler
- First device listed
- December 15, 1977
- Registered through
- 2026
- Brand names listed
- Caulk Post & Core Kit, Drills, Flex-View Interproximal Strips, GATES, Interproximal Serrated Strips, LARGO, Paper Points
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cleaner, Denture, Mechanical | JER | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Light Transmission Caries Detector | NTK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Reamer, Pulp Canal, Endodontic | EKP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 20, 2019 | K191865 | SmartLite Pro Modular LED Curing Light | EBZ | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
Compare with other makers
- All makers of Strip, Polishing Agent
- All makers of Cleanser, Denture, Over The Counter
- All makers of Point, Paper, Endodontic
- All makers of Cleaner, Denture, Mechanical
- All makers of File, Pulp Canal, Endodontic
- All makers of Drill, Dental, Intraoral
Updated November 20, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.