Manufacturer registered with FDA
Mani, Inc. (Head Office)
UTSUNOMIYA, TOCHIGI, Japan. Lists 8 dental device types with FDA across 4 registered establishments.
- Device types listed
- 8
- Brands and models
- 48
- 510(k) clearances
- 0as applicant
- Markets registered in
- 422 registrations outside the US
- Establishments
- 4Japan, Vietnam
Registered in 4 markets
Where regulators' registries name Mani, Inc. (Head Office) 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 | Mani, Inc. (Head Office) | 8 device types | — | Below |
| South Korea | MFDS | Manufacturer | Mani Hanoi Company Limited.MANI-HANOI CO., LTD. · MANI HANOI CO., LTD. · +2 | 16 | 1999–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MANI HANOI COMPANY LIMITEDMANI HANOI CO., LTD. · Mani Hanoi Co., Ltd. | 4 | 2009–2019 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MANI HANOI CO., LTD.MANI HANOI COMPANY LIMITED | 2 | — | 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 Mani, Inc. (Head Office) currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | JIZAI GLIDERMANI D FINDERSMANI FLARE FILESMANI FLARE FILES NiTiMANI FLEXILE FILESMANI GLIDE FINDERSMANI H-FILESMANI H-FILES NiTiMANI JIZAIMANI K-FILES 18 moreMANI MEDIUM FLARE FILESMANI MEDIUM FLEXILE FILESMANI MEDIUM H-FILESMANI MEDIUM K-FILESMANI MICRO FILES TYPE FMANI MICRO FILES TYPE HMANI MICRO FILES TYPE KMANI MICRO FILES TYPE UMANI NiTi FILESMANI NiTi FILES RMANI PASTE CARRIERSMANI RT FILESMANI SEC O-FILESMANI SEC O-FILES, HMANI SEC O-FILES, KMANI SUPER FILESMANI U-FILESPaste Fillers | 1982 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Gates DrillsMANI GATES DRILLSMANI PEESO REAMERSPeeso Reamers | 2002 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | MANI DIA-BURS | 2002 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | MANI CARBIDE BURSMANI STAINLESS BURSMANI STAINLESS BURS HARDMI Stainless Burs | 1992 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | FINGER SPREADERMANI FLARE SPREADERSMANI SPREADERSSPREADER | 2002 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | MANI ENGINE REAMERSMANI MEDIUM REAMERSMANI REAMERS | 1981 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | FINGER PLUGGERMANI PLUGGERSPLUGGER | 2002 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Maker | MANI SHORT BARBED BROACHES | 2002 |
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 |
|---|---|---|
| Mani Hanoi Co. LtdFDA reg. 3007791573 | Thai Nguyen Province, Vietnam | Contract manufacturer |
| MANI, INC. (HANAOKA FACTORY)FDA reg. 3004467019 | SHIOYA Tochigi, Japan | Contract manufacturer |
| MANI, INC. (HEAD OFFICE)FDA reg. 3002692886 | UTSUNOMIYA Tochigi, Japan | Manufacturer |
| MANI, INC. (TAKANEZAWA FACILITY)FDA reg. 8030343 | SHIOYA Tochigi, Japan | Contract manufacturer |
Other names on FDA records
Mani Hanoi Co., Ltd. · Mani, Inc. (Takanezawa Facility) · Mani, Inc. (Hanaoka Factory)
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030343). 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.