Manufacturer registered with FDA
Placecol S.A.
bogota, Colombia. 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
- 25,614 registrations outside the US
- Establishments
- 1Colombia
Registered in 2 markets
Where regulators' registries name Placecol S.A. 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 | Placecol S.A. | 5 device types | — | Below |
| Colombia | INVIMA | Registration holder | PLACECOL S.A | 5,614 | — | 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 Placecol S.A. 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 | exempt | 2018 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | exempt | 2018 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | exempt | 2018 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | exempt | 2018 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | exempt | 2018 |
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 |
|---|---|---|
| PLACECOL S.AFDA reg. 3014316197 | funza Cundinamarca, Colombia | Manufacturer |
Other names on FDA records
Placecol S.A.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056860). 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.