Manufacturer registered with FDA
New Phenix Home Products Manufactory Co Ltd
YANGZHOU, China. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 22
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name New Phenix Home Products Manufactory Co Ltd 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 | New Phenix Home Products Manufactory Co Ltd | 8 device types | — | Below |
| Colombia | INVIMA | Manufacturer | NEW PHENIX HOME PRODUCTS MANUFACTORY CO., LTD | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | New Phenix Home Products Manufactory Co Ltd | 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 New Phenix Home Products Manufactory Co Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Dental Mirror | 2016 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Dr. SmithHetrasOral Care Toothbrush & ToothpasteOral Care Toothbrush,Squeezie | 2003 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Dr Smith Brand Relief WaxLummarx Brand Orthodontic WaxOral-Care | 2008 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Dental pick | 2016 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dr. SmithMy StuffNATURAL BRIGHT FLOSSEROral-CareVastliv | 2003 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Toothpick | 2022 |
| Tongue ScraperLCN · Class 1 | — | Maker | Dr. SmithOral-CareTONGUE SCRAPER | 2007 |
| Dental Stain EraserMAU · Class 1 | — | Maker | DENTAL STAIN ERASERDr. SmithOral-Care | 2007 |
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 |
|---|---|---|
| NEW PHENIX HOME PRODUCTS MANUFACTORY CO., LTD.FDA reg. 3003994666 | YANGZHOU Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9055600). 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.