Manufacturer registered with FDA
Leda Innovations USA Inc.
Brookline, MA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Thailand
Devices listed with FDA
What Leda Innovations USA 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 |
|---|---|---|---|---|
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | REX ENTERPRISES CO. LTD.Rex Enterprises Co., Ltd. | 2026 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Maker | REX ENTERPRISES CO. LTD.Rex Enterprises Co., Ltd. | 2026 |
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 |
|---|---|---|
| Rex Enterprises Co., Ltd.FDA reg. 3002857192 | Nakhon Pathom City, Thailand | Foreign exporter, Manufacturer |
Other names on FDA records
Rex Enterprises Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095686, 10096670). 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.