Data / Medical devices / United States / Allure Ortho
Allure Ortho: FDA-registered device maker in Whitinsville, MA, United States, 1 510(k) clearance
Allure Ortho is registered with the FDA (registration 3012771684) in Whitinsville, MA, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 16, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012771684
- Address
- 1 Main St #10, Whitinsville, MA, United States, 01588
- Owner or operator
- ALLURE ORTHO (10052651)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- September 1, 2016
- Registered through
- 2026
- Brand names listed
- EC CERTIFICATION
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Specification developer | accessdata.fda.gov |
| Aligner, Bracket, Orthodontic | ECQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Specification developer | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Specification developer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Specification developer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Repackager or relabeler | 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 16, 2022 | K221194 | LEDEX | EBZ | Substantially Equivalent | Dentmate Technology Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Band, Preformed, Orthodontic
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Cleaner, Ultrasonic, Medical Instrument
- All makers of Tube, Orthodontic
- All makers of Instruments, Dental Hand
- All makers of Protector, Dental
Updated September 16, 2022. 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.