Z45L

GUDID 04560264574083

NAKANISHI INC.

Dental power tool system handpiece, line-powered

Primary Device ID	04560264574083
NIH Device Record Key	05b59128-c19b-4f13-99f9-816cc63499ac
Commercial Distribution Status	In Commercial Distribution
Brand Name	Z45L
Version Model Number	Z45L
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	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	04560264547377 [Direct Marking]
GS1	04560264574083 [Primary]
GS1	04589551383344 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121901

FDA Product Code

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

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

[04560264574083]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-01-03
Device Publish Date	2021-12-24

Devices Manufactured by NAKANISHI INC.

04589551383993 - Bur Stopper	2024-11-21
04589551384006 - Bur Stopper Puller	2024-11-21
04560264502963 - PTL Nozzle	2024-11-11
04560264502970 - EZ-M4 Adaptor	2024-11-11
04589551392063 - EZ SPRAY	2024-11-11
04589551391950 - M205	2024-10-24
04560264578586 - FX204 M4	2024-10-24
04589551389391 - Surgic Pro2 OPT	2024-10-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.