Manufacturer registered with FDA
Straits Orthopaedics (Mfg) Sdn Bhd
Bandar Cassia, Malaysia. Lists 4 dental device types with FDA across 3 registered establishments.
- Device types listed
- 4
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 537 registrations outside the US
- Establishments
- 3Malaysia
Registered in 5 markets
Where regulators' registries name Straits Orthopaedics (Mfg) Sdn Bhd 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 | Straits Orthopaedics (Mfg) Sdn Bhd | 4 device types | — | Below |
| Colombia | INVIMA | Manufacturer | STRAITS ORTHOPAEDICS (MFG) SDN BHD | 17 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Straits Orthopaedics (MFG) Sdn BhdSTRAITS ORTHOPAEDICS (MFG) SDN BHD · Straits Orthopaedics (Mfg) Sdn Bhd | 15 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | STRAITS ORTHOPAEDICS (MFG) SDN. BHD.STRAITS ORTHOPAEDICS (MFG) SDN BHD · Straits Orthopaedics（MFG）SDN BHD | 4 | 2012–2018 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Straits Orthopaedics (MFG) SDN. BHD. | 1 | 2017–2017 | 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 Straits Orthopaedics (Mfg) 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 |
|---|---|---|---|---|
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | 5100 215 306 BEARING SPACER5100-010-028 BEARING PRELOAD RING5100-010-239 BEARING SLEEVE5110-901-912 NOZZLE | 2025 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | 5400-007-017 PRESS RING5400-007-018 THIN BRONZE WASHER5400-007-020 LIGHT PIPE5400-007-023 THICK BRONZE WASHER | 2025 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | 5100 215 306 BEARING SPACER5110-901-912 NOZZLE | 2025 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | Femoral Box Chisel (80300040) | 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 |
|---|---|---|
| STRAITS ORTHOPAEDICS (MFG) SDN BHDFDA reg. 3036756245 | Perai Pulau Pinang, Malaysia | Contract manufacturer |
| STRAITS ORTHOPAEDICS (MFG) SDN BHDFDA reg. 3033509898 | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer |
| STRAITS ORTHOPAEDICS (MFG) SDN BHDFDA reg. 3025603301 | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048319). 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.