Manufacturer registered with FDA
Dental Morelli
Sorocaba, Brazil. Lists 25 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 25
- Brands and models
- 0
- 510(k) clearances
- 22013–2014
- Markets registered in
- 91,296 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Dental Morelli 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 | Dental Morelli | 2 clearances | 2013–2014 | Below |
| European Union | EUDAMED | Manufacturer | DENTAL MORELLI LTDA. | 908 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | DENTAL MORELLI LTDA | 259 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Dental Morelli Ltda | 63 | 1999–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Dental Morelli LtdaDENTAL MORELLI LTDA · Dental Morelli Ltda. | 29 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DENTAL MORELLI LTDADENTAL MORELLI LTDA. · DENTAL MORELLI Ltda. | 19 | 2013–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DENTAL MORELLI LTDADental Morelli Ltda | 12 | 2018–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Dental Morelli Ltda | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Dental Morelli Ltda. | 1 | 2018–2018 | 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 Dental Morelli currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Dental Morelli as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTAL MORELLI LTDA.FDA reg. 9681207 | SOROCABA Sao Paulo, Brazil | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9020620). 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.