Z99L

GUDID 04589551391592

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, electric
Primary Device ID04589551391592
NIH Device Record Keyb97f1af8-8656-472b-bd13-f20e29766a4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ99L
Version Model NumberZ99L
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104589551391585 [Primary]
GS104589551391592 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EGSHandpiece, contra- and right-angle attachment, dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


[04589551391592]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-29
Device Publish Date2025-05-21

Devices Manufactured by NAKANISHI INC.

04589551391592 - Z99L2025-05-29
04589551391592 - Z99L2025-05-29
04589551392667 - Tip Remover2025-05-26
04560264523913 - Ring Wrench2025-03-31
04560264524019 - Cleaning Wire2025-03-31
04560264524026 - Cleaning Wire2025-03-31
04560264524033 - Cleaning File2025-03-31
04560264524040 - Cleaning Brush2025-03-31
04560264546158 - Nozzle Tip Remover2025-03-31

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