V files

GUDID 04560264562981

NAKANISHI INC.

Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable

Primary Device ID	04560264562981
NIH Device Record Key	d1fcfbaa-81b5-4422-b924-81ceb4b86792
Commercial Distribution Status	In Commercial Distribution
Brand Name	V files
Version Model Number	V-U25
Company DUNS	690710546
Company Name	NAKANISHI INC.
Device Count	6
DM Exempt	true
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	true
Serial Number	false
Manufacturing Date	false
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	04560264562981 [Primary]
GS1	04560264565289 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991021

FDA Product Code

ELC	Scaler, ultrasonic