Dental device manufacturers in Malaysia
24 companies have an FDA-registered establishment in Malaysia, across 28 sites. 19 manufacture dental devices there or own their specifications.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Materialise NV | Belgium | Maker | ProPlan CMF Guides · SurgiCase CMF Guides · TruMatch CMF Ti 3D-Printed Implants · TruMatch CMF Ti 3D-Printed Plates · +10 | 5 | 2026 |
| The Hygenic Company, LLC | United States | Maker | Elasti-Dam · Fiesta Dental Dam · Flexi Dam Non-Latex · Framed Flexi Dam Non-Latex · +3 | 13 | 1996 |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Aesculap · Forceps · Retractor · Periodontic Probe · +7 | — | — |
| Straits Orthopaedics (Mfg) Sdn Bhd | Malaysia | Maker | 5100 215 306 BEARING SPACER · 5100-010-028 BEARING PRELOAD RING · 5100-010-239 BEARING SLEEVE · 5110-901-912 NOZZLE · +5 | — | — |
| Unip Berhad | Malaysia | Maker | MANUAL DENTAL · WAX · IMPRESSION TRAY · Cheek Retractor : Zoom Retractors · +4 | — | — |
| Greatcare 4u sdn bhd | Malaysia | Maker | Disposable saliva ejector · Disposable endo irrigation needles · Disposable curved tip syringe, Disposable flow tip (pre-bent multipurpose dispensing tip) · Dental bibs · +3 | — | — |
| Fitson Sdn Bhd | Malaysia | Maker | Allegre Puericulture SAS · Hegen Pte Ltd · Laboratoires Polive · Nurnberg Gummi Babyartikel GmbH & Co. Kg · +1 | — | — |
| Hainan Lunarsea Personal Care Supplies Sdn. Bhd. | China | Maker | Dental Mirror · Tooth brush · Dental Hook · Electric Toothbrush · +1 | — | — |
| Cross Protection M Sdn. Bhd. | Malaysia | Maker | Cross Protection Saliva Ejector · Cross Protection Saliva Ejector Tip | — | — |
| Lam Seng Plastics Industries Sdn Bhd | Malaysia | Maker | Jordan · Step 0 Teether and Training | — | — |
| Sanctuary Health Sdn Bhd | Malaysia | Maker | Sanctuary ComfiTract Latex- Free Cheek Retractor · Dental Dam Premium Kit | — | — |
| Labchem Sdn. Bhd. | Malaysia | Maker | TOOTHBRUSH, MANUAL | — | — |
| Peri-dent Ltd. | United Kingdom | Maker | dental floss | — | — |
| Pintarmas Sdn Bhd | Malaysia | Maker | Hydro Station | — | — |
| Avalanche Med Sdn Bhd | Malaysia | Maker | — | — | — |
| K-One MediTech Sdn. Bhd | Malaysia | Maker | — | — | — |
| Pak Mane Brush Limited | Hong Kong SAR China | Maker | — | — | — |
| TG Medical Sdn Bhd | Malaysia | Maker | — | — | — |
| Elastomade Accessories Sdn Bhd | Malaysia | Lister | Dental Dam · Royal Shield Latex Free Dental Dam | 3 | 1995 |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | Aesculap · AESCULAP · Forceps · Retractor · +8 | — | — |
| Fulijaya Manufacturing Sdn Bhd | Malaysia | Foreign exporter | — | — | — |
| TG Worldwide Sdn. Bhd. | Malaysia | Foreign exporter | — | — | — |
| Transmedic Healthcare Sdn. Bhd. | Malaysia | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026