FX25K

GUDID 04589551387175

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric

Primary Device ID	04589551387175
NIH Device Record Key	f0ebbe01-b917-4adc-b934-a20714c70fe8
Commercial Distribution Status	In Commercial Distribution
Brand Name	FX25K
Version Model Number	FX25K
Company DUNS	690710546
Company Name	NAKANISHI INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04589551387175 [Direct Marking]
GS1	04589551388462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K222518

FDA Product Code

EGS	Handpiece, contra- and right-angle attachment, dental