Manufacturer registered with FDA
Breech Oral Care Pvt Ltd
Vadodara, India. 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
- 260 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name Breech Oral Care Pvt Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Breech Oral Care Pvt Ltd | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | BREECH ORALCARE PVT, LTD.BREECH ORALCARE PVT. LTD · BREECH ORALCARE PVT. LTD. · +1 | 60 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Breech Oral Care Pvt Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | — | 2019 |
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 |
|---|---|---|
| BREECH ORAL CARE PVT LTDFDA reg. 3011448174 | Vadodara Gujarat, India | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060023). 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.