Data / Medical devices / Device, Caries Detection
Device, Caries Detection (LFC): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make Device, Caries Detection (product code LFC, Class 2, 21 CFR 872.1740). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on May 16, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LFC
- Device class
- 2
- Regulation
- 872.1740
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Australia | 1 |
| Japan | 1 |
| United Kingdom | 1 |
Makers of Device, Caries Detection
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Incisive Technologies Pty Ltd | Ferntree Gully Victoria, Australia | Manufacturer | 1 | May 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Kuraray Noritake Dental Niigata Plant | TAINAI Niigata, Japan | Manufacturer | 1 | September 14, 2001 | 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 |
| Marturion Electronics Ltd | Lisburn Northern Ireland, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silgan Unicep Packaging, LLC. | Sandpoint, ID, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 16, 2023. 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.