Data / Medical devices / United States / Progressive Aligners
Progressive Aligners: FDA-registered device maker in Aliso Viejo, CA, United States, 1 510(k) clearance
Progressive Aligners is registered with the FDA (registration 3013342228) in Aliso Viejo, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 11, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013342228
- Address
- 135 Columbia Street, Ste #101, Aliso Viejo, CA, United States, 92656
- Owner or operator
- Progressive Aligners Inc (10087498)
- Roles
- Specification developer
- First device listed
- March 6, 2023
- Registered through
- 2026
- Brand names listed
- Medit Orthodontic Suite, Progressive Orthodontics App
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Bracket, Orthodontic | ECQ | 1 | Specification developer | accessdata.fda.gov |
| Orthodontic Software | PNN | 2 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | 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 |
|---|---|---|---|---|---|---|
| October 11, 2024 | K241153 | Progressive Orthodontics App | PNN | Substantially Equivalent | Progressive Aligners, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Aligner, Bracket, Orthodontic
- All makers of System, Image Processing, Radiological
- All makers of Orthodontic Software
Updated October 11, 2024. 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.