Data / Medical devices / Laser, Dental, Soft Tissue / United States
FDA-registered makers of Laser, Dental, Soft Tissue in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Laser, Dental, Soft Tissue (product code NVK). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Laser, Dental, Soft Tissue
- Product code
- NVK
- Country
- United States
Makers of Laser, Dental, Soft Tissue in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Azena Medical | Walnut Creek, CA, United States | Manufacturer, Specification developer | 2 | March 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biolase MG LLC | Corona, CA, United States | Complaint file establishment, Manufacturer | 1 | December 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Biolase MG LLC | Foothill Ranch, CA, United States | Specification developer | 1 | December 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Convergent Dental | Waltham, MA, United States | Manufacturer | 1 | September 14, 2022 | 0 | 1 | 0 | api.fda.gov |
| Dentlight Inc. | Plano, TX, United States | Manufacturer | 1 | February 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| All Quality & Services, Inc. | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cao Group, Inc. | W Jordan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.