Registered with FDA
Elastomade Accessories Sdn Bhd
Port Klang, Malaysia. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 31991–1995
- Markets registered in
- 525 registrations outside the US
- Establishments
- 1Malaysia
510(k) clearances per year, 1990–2026
Registered in 5 markets
Where regulators' registries name Elastomade Accessories 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 | Lister | Elastomade Accessories Sdn Bhd | 3 clearances | 1991–1995 | Below |
| Malaysia | MDA | Registration holder | ELASTOMADE ACCESSORIES SDN. BHD. | 14 | 2024–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | ELASTOMADE ACCESSORIES SDN. BHD. | 8 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ELASTOMADE ACCESSORIES SDN. BHD. | 2 | 2015–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Elastomade Accessories SDN, BHD. | 1 | 2001–2001 | 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 Elastomade Accessories 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 |
|---|---|---|---|---|
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | Dental DamRoyal Shield Latex Free Dental Dam | 2008 |
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 Elastomade Accessories Sdn Bhd as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ELASTOMADE ACCESSORIES SDN BHDFDA reg. 3005822857 | Port Klang Selangor, Malaysia |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9001465). 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.