Manufacturer registered with FDA
Hebei Mita Biotechnology Limited
Hong Kong, Hong Kong SAR China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Hong Kong SAR China
Devices listed with FDA
What Hebei Mita Biotechnology Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149,OMG150,OMG-PST001,D03,OMD76,OM167,OMG-PST002,OMG-PST003,OMG-QYF0013,XOM-QYF001 | 2025 |
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 |
|---|---|---|
| HEBEI MITA BIOTECHNOLOGY LIMITEDFDA reg. 3043011436 | Hong Kong, Hong Kong SAR China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094693). 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.