SG80M

GUDID 04560264565760

NAKANISHI INC.

Dental surgical power tool motor, electric
Primary Device ID04560264565760
NIH Device Record Key2f295962-4d6a-4fd7-a8c2-d1f5723403f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSG80M
Version Model NumberSG80M
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
GS104560264565760 [Direct Marking]
GS104589551389438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


[04560264565760]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-23
Device Publish Date2024-10-15

Devices Manufactured by NAKANISHI INC.

04560264575158 - Nozzle Holder2024-11-25
04560264575165 - Nozzle Holder2024-11-25
04560264575172 - Internal Spray Nozzle2024-11-25
04560264575189 - Cleaning Wire2024-11-25
04560264575271 - Tube Holder2024-11-25
04560264576506 - Protection Plug2024-11-25
04560264576513 - Coolant Solution Hanger Post2024-11-25
04589551392421 - Tube Holder2024-11-25

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