Manufacturer registered with FDA
Air Water Realize Inc.
Kasama-shi, Japan. Lists 2 dental device types with FDA across 2 registered establishments.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 760 registrations outside the US
- Establishments
- 2Japan
Registered in 7 markets
Where regulators' registries name Air Water Realize Inc. 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 | Air Water Realize Inc. | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | AIR WATER REALIZE INC. | 54 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AIR WATER REALIZE INC. | 2 | 1996–2022 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | AIR WATER REALIZE INC. | 1 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Air Water Realize INC. | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Air Water Realize Inc. | 1 | 2022–2022 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | AIR WATER REALIZE INC. | 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 Air Water Realize Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | — | 2006 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2006 |
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 |
|---|---|---|
| AIR WATER REALIZE INC.FDA reg. 9612124 | IWAKI-SHI Fukushima, Japan | Contract manufacturer |
| AIR WATER REALIZE INC.FDA reg. 3017024395 | Kasama-shi Ibaraki, Japan | Contract manufacturer, Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030380). 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.