Registered with FDA
HYDY, Inc.
Chicago, IL, United States. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What HYDY, 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | Boka Power Flosser | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Boka Classic Toothbrush | 2023 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | Boka Brush 2 | 2023 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Boka Floss | 2023 |
| Tongue ScraperLCN · Class 1 | — | Lister | Boka Stainless Steel Tongue Scraper | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Sargas LLC/ Sabik LLC/ Karaka LLC/Archernar LLCFDA reg. 3019804885 | Chicago, IL, United States | Repacker / relabeler |
Other names on FDA records
Sargas LLC/ Sabik LLC/ Karaka LLC/Archernar LLC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10082377). 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.