iSD900

Basic Information

• Brand Name: iSD900
• Primary DI: 04560264521865
• Version / Model: iSD900 Motor
• Company Name: NAKANISHI INC.
• Labeler DUNS: 690710546
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-19
• Public Version: 2
• Public Version Date: 2023-10-12
• Public Version Status: Update
• Public Device Record Key: 9f9ae25f-cdce-42f4-b12f-48e166e47df1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKX	Handpiece, direct drive, ac-powered	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43894	Power tool torque control unit	A mains electricity (AC-powered) unit that is connected to a power tool or a power tool system and used to regulate the torque effect of that power tool. This is to give the tool greater or lesser torque effect assisting in the power requirement of the intervention being carried out, e.g., a screwdriver for the insertion and tightening of orthopaedic fixation screws, tooth prosthesis anchoring screws.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560264521865	GS1

Premarket Submissions

Submission Number	Supplement Number
K110278	000