Manufacturer registered with FDA
Unip Berhad
Cheras,, Malaysia. Lists 8 dental device types with FDA across 2 registered establishments.
- Device types listed
- 8
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 2Malaysia
Registered in 2 markets
Where regulators' registries name Unip Berhad 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 | Unip Berhad | 8 device types | — | Below |
| Colombia | INVIMA | Manufacturer | SINORITA SENDIRIAN BERHAD | 1 | — | 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 Unip Berhad currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | MANUAL DENTAL | 2004 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | WAX | 2004 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | IMPRESSION TRAY | 2014 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Cheek Retractor : Zoom Retractors | 2020 |
| Operative Margin Finishing FileEKA · Class 1 | Dental hand instruments | Maker | STRIP | 2016 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | DENTAL FLOSS THREADERS | 2006 |
| Tongue ScraperLCN · Class 1 | — | Maker | TONGUE SCRAPER | 2013 |
| Root Canal Irrigation Air-Powered HandpieceNYL · Class 1 | — | Maker | ENDOVAC HANDPIECE, AIR-POWERED, ROOT CANAL IRRIGATION SYRINGE | 2014 |
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 |
|---|---|---|
| SINORITA SENDIRIAN BERHADFDA reg. 3003940985 | CHERAS Selangor, Malaysia | Contract manufacturer, Manufacturer |
| UNIP PLASTIC INDUSTRIES SDN BHDFDA reg. 3003361112 | CHERAS Selangor, Malaysia | Contract manufacturer, Repacker / relabeler |
Other names on FDA records
Sinorita Sendirian Berhad · Unip Plastic Industries Sdn. Bhd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9063902). 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.