Manufacturer registered with FDA
Palmero Healthcare
Northbrook, IL, United States. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 43 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name Palmero Healthcare 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 | Palmero Healthcare | 7 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Palmero Healthcare LLC | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Palmero Health Care | 1 | 2005–2005 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Palmero Health Care | 1 | 2011–2011 | 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 Palmero Healthcare currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Saliva Ejector Screen | 2020 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | — | 2016 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Syringe Tip Cover | 2020 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | HVEsolo | 2019 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | Matrix Strips | 2021 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | Vacuum CleanVacuum Shock | 2020 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Air/Water Syringe ProtectorBarrier FilmBite Block CoverChair ProtectorHead Rest ProtectorT-Light ProtectorTube ProtectorX-Ray Head ProtectorX-Ray Unit Protector | 2020 |
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 |
|---|---|---|
| PALMERO HEALTHCARE LLCFDA reg. 1219113 | Northbrook, IL, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1219113). 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.