Manufacturer registered with FDA
CFS Dental Inc.
Hialeah, FL, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What CFS Dental Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | — | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
CFS Dental Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Comfort and Flexible Systems (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Jan 2009 | K081537 | CFS FLEXIBLE | Comfort and Flexible Systems | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CFS DENTAL INCFDA reg. 3008590411 | Hialeah, FL, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033716). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.