Data / Medical devices / Device, Caries Detection / United States
FDA-registered makers of Device, Caries Detection in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Device, Caries Detection (product code LFC). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Device, Caries Detection
- Product code
- LFC
- Country
- United States
Makers of Device, Caries Detection in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Centrix, Inc. | Shelton, CT, United States | Manufacturer | 1 | November 15, 1996 | 0 | 0 | 0 | api.fda.gov |
| GreenMark Biomedical Lab | Ann Arbor, MI, United States | Manufacturer | 1 | March 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer | 1 | January 17, 1997 | 0 | 0 | 0 | api.fda.gov |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer | 1 | September 5, 1995 | 0 | 0 | 0 | api.fda.gov |
| Zest Anchors, LLC | Carlsbad, CA, United States | Repackager or relabeler, Specification developer | 1 | February 8, 1996 | 0 | 0 | 0 | api.fda.gov |
| Silgan Unicep Packaging, LLC. | Sandpoint, ID, United States | Contract 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.