Data / Medical devices / United States / Dentsply Sirona Orthodontics Inc.
Dentsply Sirona Orthodontics Inc.: FDA-registered device maker in Richardson, TX, United States, 4 510(k) clearances
Dentsply Sirona Orthodontics Inc. is registered with the FDA (registration 1649995) in Richardson, TX, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1649995
- FEI number
- 3001947560
- Address
- 1125 E Campbell Rd Ste 100, Richardson, TX, United States, 75081
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Specification developer
- First device listed
- August 12, 1992
- Registered through
- 2026
- Brand names listed
- SureSmile Advanced Software, SureSmile Advanced Software v 7.6, SureSmile Aligner, SureSmile Aligner Software, SureSmile Aligner Software v 7.6, SureSmile Aligner Transfer Tray, SureSmile Aligners, SureSmile Aligners Attachment Tray and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Specification developer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Specification developer | accessdata.fda.gov |
| Orthodontic Software | PNN | 2 | Specification developer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Specification developer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Specification developer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 15, 2026 | K260722 | SureSmile Aligner (ASSY500020) | NXC | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| March 4, 2026 | K253565 | SureSmile Software | PNN | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| January 5, 2018 | K171860 | Sureclear aligners | NXC | Substantially Equivalent | Emergo Global Consulting, LLC | accessdata.fda.gov |
| November 16, 2000 | K002620 | SURESMILE SYSTEM | EIA | Substantially Equivalent | Orametrix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental
- All makers of Positioner, Tooth, Preformed
- All makers of Orthodontic Software
- All makers of Aligner, Sequential
- All makers of Wire, Orthodontic
- All makers of Indirect Bonding Tray
Updated April 15, 2026. 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.