MANI, INC. (HEAD OFFICE)

Registration Details

Registration Name: MANI, INC. (HEAD OFFICE)
Registration Number: 3002692886
FEI Number: 3002692886
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 8-3, KIYOHARA INDUSTRIAL PARK,
City: UTSUNOMIYA Tochigi
Country: JP

Regulatory Submissions

510(k) Number: K053636

Owner / Operator

Firm Name: MANI, INC. (HEAD OFFICE)
Operator Number: 8030343
Address: 8-3 KIYOHARA INDUSTRIAL PARK, --
City: UTSUNOMIYA, TOCHIGI
State: JP-NOTA
Postal Code: 321-3231
Country: JP
Correspondent: Toshiharu Kamei

US Agent

Business Name: Emergo Global Representation LLC
Contact Name: Yong Sun
Address: 2500 Bee Cave Rd., Bldg. 1, Ste. 300
City: Austin
State: TX
ZIP: 78746
Country: US
Email: [email protected]
Phone: 512 3279997

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
File, Pulp Canal, Endodontic	EKS	Class 1	Dental	No	1982-08-06
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	Class 2	General, Plastic Surgery	No	2007-04-19
Knife, Ent	KTG	Class 1	Ear, Nose, Throat	No	2018-09-12
Broach, Endodontic	EKW	Class 1	Dental	No	2002-10-29
Blade, Scalpel	GES	Class 1	General, Plastic Surgery	No	2010-05-14
Bur, Dental	EJL	Class 1	Dental	No	1992-12-03
Suture, Nonabsorbable, Silk	GAP	Class 2	General, Plastic Surgery	No	2007-04-19
Staple, Removable (Skin)	GDT	Class 1	General, Plastic Surgery	No	2022-04-27
Cannula, Trocar, Ophthalmic	NGY	Class 1	Ophthalmic	No	2009-08-11
Spreader, Pulp Canal Filling Material, Endodontic	EKK	Class 1	Dental	No	2002-05-01
Drill, Dental, Intraoral	DZA	Class 1	Dental	No	2002-06-26
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	Class 2	General, Plastic Surgery	No	2007-04-19
Instrument, Diamond, Dental	DZP	Class 1	Dental	No	2002-06-26
Forceps, Ophthalmic	HNR	Class 1	Ophthalmic	No	2026-02-09
Plugger, Root Canal, Endodontic	EKR	Class 1	Dental	No	2002-05-01
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	Class 2	General, Plastic Surgery	No	2007-04-19
Needle, Suturing, Reusable	GDL	Class 1	General, Plastic Surgery	No	2007-04-19
Reamer, Pulp Canal, Endodontic	EKP	Class 1	Dental	No	1981-10-01
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	PAW	Class 2	Cardiovascular	No	2021-04-20
Knife, Ophthalmic	HNN	Class 1	Ophthalmic	No	2002-05-01

Proprietary Names

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 Sutures, Ophthalmic Sutures ( with needle) MANI Sutures PGA MANI ENT Knife MANI SHORT BARBED BROACHES MANI DISPOSABLE VESSEL KNIFE MI Stainless Burs MANI STAINLESS BURS MANI STAINLESS BURS HARD MANI CARBIDE BURS MANI Sutures, Ophthalmic Sutures ( with Needle) Sutures (with needle) MANI Sutures Silk Manipler DSX 35W Manipler AZ 35W MANI Plug MANI Trocar Kit MANI Trocar MANI Infusion Cannula MANI SPREADERS FINGER SPREADER MANI FLARE SPREADERS SPREADER Peeso Reamers Gates Drills MANI GATES DRILLS MANI PEESO REAMERS MANI Sutures Nylon MANI DIA-BURS MANI MICRO FORCEPS MANI PLUGGERS FINGER PLUGGER PLUGGER MANI Sutures, Ophthalmic Sutures (with Needle) MANI Sutures Polyester MANI MEDIUM REAMERS MANI REAMERS MANI ENGINE REAMERS MANI Ophthalmic Knife Straight MANI TRABECULOTOMY HOOK MANI Ophthalmic Knife Guard Crescent Double Step - Angled 1 mm Slit MPK Golf/Scleral Rslit (Implant) MANI Ophthalmic Knife MVR

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)