Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030343

FEI Number

1000550480

Entity Name

MANI, INC. (TAKANEZAWA FACILITY)

City/State/Country

SHIOYA Tochigi, JP

Establishment Address

743 NAKAAKUTSU, TAKANEZAWA, SHIOYA Tochigi 329-1234, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MANI, INC. (HEAD OFFICE) (Owner Number: 8030343)

Owner / Operator Contact Address

8-3 KIYOHARA INDUSTRIAL PARK, --, UTSUNOMIYA, TOCHIGI, JP-NOTA 321-3231, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MANI PLUGGERS FINGER PLUGGER PLUGGER MANI DIA-BURS MI Stainless Burs MANI STAINLESS BURS MANI STAINLESS BURS HARD MANI CARBIDE BURS MANI SPREADERS FINGER SPREADER MANI FLARE SPREADERS SPREADER Peeso Reamers Gates Drills MANI GATES DRILLS MANI PEESO REAMERS Paste Fillers MANI GLIDE FINDERS MANI JIZAI MANI H-FILES MANI FLEXILE FILES MANI PASTE CARRIERS JIZAI GLIDER MANI MEDIUM FLEXILE FILES MANI MICRO FILES TYPE H MANI FLARE FILES MANI K-FILES MANI MEDIUM FLARE FILES MANI SEC O-FILES, H MANI RT FILES MANI FLARE FILES NiTi MANI SEC O-FILES, K MANI MICRO FILES TYPE K MANI H-FILES NiTi MANI NiTi FILES MANI MICRO FILES TYPE F MANI SUPER FILES MANI MEDIUM H-FILES MANI MEDIUM K-FILES MANI D FINDERS MANI MICRO FILES TYPE U MANI SEC O-FILES MANI NiTi FILES R MANI U-FILES MANI SHORT BARBED BROACHES MANI MEDIUM REAMERS MANI REAMERS MANI ENGINE REAMERS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2002-05-01
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2002-06-26
EJL	Bur, Dental	Dental	Class 1	872.3240	1992-12-03
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2002-05-01
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2002-06-26
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	1982-08-06
EKW	Broach, Endodontic	Dental	Class 1	872.4565	2002-10-29
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	1981-10-01

Official Correspondent

Toshiharu Kamei

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

MANI, INC. (HEAD OFFICE)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004467019	MANI, INC. (HANAOKA FACTORY)	SHIOYA Tochigi, JP
3007791573	Mani Hanoi Co. Ltd	Thai Nguyen Province, VN
3002692886	MANI, INC. (HEAD OFFICE)	UTSUNOMIYA Tochigi, JP
3014276972	Mani Hanoi Co. Ltd Pho Yen 2 Factory	Thai Nguyen Province, VN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Similar Registrations

Registration Number	Establishment Name	Location
3007064566	POMEE CORPORATION	Sialkot Punjab, PK
3005067367	SHANGHAI MEDICAL INSTRUMENTS (GROUP) LTD. CORP.	Shanghai, CN
8010159	A. SCHWEICKHARDT GMBH & CO. KG	Seitingen-Oberflacht Baden-Wurttemberg, DE
3008808049	SURGICRAFTS	Sialkot Punjab, PK
3004168759	CENTRAL SURGICAL CO. PVT. LTD.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030343. Last updated year: 2026. Please use registration number 8030343 when referencing this establishment in official correspondence.