FDA Registration Active 🇺🇸 United States

Ti25L

Reg #: 1422375 · FEI: 1000139790 · Expires 2025
Products
1
Proprietary Names
43
Establishment Types
2
Classifications
1

Registration Details

Registration Name
NSK AMERICA CORP.
Registration Number
1422375
FEI Number
1000139790
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
1800 Global Parkway
City
Hoffman Est
State
IL
ZIP
60192
Country
US

Regulatory Submissions

510(k) Number
K972569

Owner / Operator

Firm Name
NAKANISHI INC.
Operator Number
8030216
Address
1800 Global Pkwy
City
Hoffman Est
State
IL
Postal Code
60192
Country
US
Correspondent
Satoru Ikeda

Products

Device Name Product Code
Handpiece, Contra- And Right-Angle Attachment, Dental EGS

Proprietary Names

Ti25L Ti15L Ti15 Ti55L X57 Ti70L Ti55 Ti25LA X70 Ti20L Ti25 X20 X35L Ti75 Ti45 M65 X10 E-TYPE SPEED INCREASER CONTRA ANGLE Ti85LA X35 X75L X55L Ti95EX Ti57 FPB-E Ti45L Ti95 Ti35L Ti20 X75 X55 Ti10LA ES-95 Ti10 Ti35 X70L Ti85 Ti95LA Ti95L X57L Ti85L X10L X95EX

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device