Data / Medical devices / United States / ClearCorrect, LLC
ClearCorrect, LLC: FDA-registered device maker in Round Rock, TX, United States, 2 510(k) clearances
ClearCorrect, LLC is registered with the FDA (registration 3007130440) in Round Rock, TX, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 6, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007130440
- Address
- 21 Cypress Blvd Ste 1010, Round Rock, TX, United States, 78665
- Owner or operator
- INSTITUT STRAUMANN AG (9005052)
- Roles
- Manufacturer
- First device listed
- June 11, 2020
- Registered through
- 2027
- Brand names listed
- REF02 ClearCorrect System Engager Template, REF03 ClearCorrect System Aligners (Multi-layer), REF04 ClearCorrect System Retainer, REF05 ClearCorrect System Aligner (Single Layer), REF06 ClearCorrect System Engager Template
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | 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 |
|---|---|---|---|---|---|---|
| August 6, 2021 | K210320 | ClearCorrect System | NXC | Substantially Equivalent | Clearcorrect, LLC | accessdata.fda.gov |
| March 19, 2012 | K113618 | CLEARCORRECT SYSTEM | NXC | Substantially Equivalent | Clearcorrect, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Indirect Bonding Tray
- All makers of Aligner, Sequential
- All makers of Positioner, Tooth, Preformed
Updated August 6, 2021. 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.