Data / Medical devices / Belgium / DENTSPLY Implants N.V.
DENTSPLY Implants N.V.: FDA-registered device maker in Hasselt Limburg, Belgium, 4 510(k) clearances
DENTSPLY Implants N.V. is registered with the FDA (registration 3007362683) in Hasselt Limburg, Belgium. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 2, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007362683
- Address
- Research Campus 10, Hasselt Limburg, Belgium, B-3500
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 23, 2001
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 2, 2020 | K193405 | Simplant Digital Guide | NDP | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| March 3, 2020 | K193064 | Atlantis suprastructures | NHA | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| April 4, 2018 | K172239 | SIMPLANT 18 | LLZ | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| July 28, 2016 | K161118 | SIMPLANT Online Case Review and SIMPLANT Editor | LLZ | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of System, Image Processing, Radiological
- All makers of Abutment, Implant, Dental, Endosseous
Updated September 2, 2020. 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.