Manufacturer registered with FDA
Greatcare 4u sdn bhd
Selangor Darul Ehsan, Malaysia. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Malaysia
Devices listed with FDA
What Greatcare 4u sdn bhd 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 | — | Maker | Disposable saliva ejector | 2025 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Disposable endo irrigation needles | 2025 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Disposable curved tip syringe, Disposable flow tip (pre-bent multipurpose dispensing tip) | 2025 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental bibs | 2025 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Disposable micro applicators | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Headrest cover | 2025 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | HEADREST COVER | 2025 |
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 |
|---|---|---|
| GREATCARE 4U SDN BHDFDA reg. 3038285060 | Selangor Darul Ehsan, Malaysia | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093267). 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.