Data / Medical devices / United States / Celebrace
Celebrace: FDA-registered device maker in Colleyville, TX, United States, 1 510(k) clearance
Celebrace is registered with the FDA (registration 3033714666) in Colleyville, TX, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033714666
- Address
- 5708 Colleyville Blvd Ste B, Colleyville, TX, United States, 76034
- Owner or operator
- Celebrace (10091420)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 3, 2024
- Registered through
- 2026
- Brand names listed
- Celebrace AI Wire, Celebrace Bonding Tray, Celebrace Custom Brackets, Celebrace Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Metal, Orthodontic | EJF | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthodontic Software | PNN | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 29, 2025 | K253343 | Celebrace Software | PNN | Substantially Equivalent | Celebrace | accessdata.fda.gov |
Compare with other makers
- All makers of Orthodontic Software
- All makers of Bracket, Metal, Orthodontic
- All makers of Wire, Orthodontic
- All makers of Indirect Bonding Tray
Updated December 29, 2025. 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.