TUN Ultrasonic Tip

GUDID 00850440008278

TUN Ultrasonic Tip

Engineered Endodontics, LLC

Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Primary Device ID00850440008278
NIH Device Record Key2c0f59d6-c785-4910-9ff6-cf454dc424c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTUN Ultrasonic Tip
Version Model NumberR2
Company DUNS079892178
Company NameEngineered Endodontics, LLC
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850440008278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


[00850440008278]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-12
Device Publish Date2026-01-02

On-Brand Devices [TUN Ultrasonic Tip]

00850440008926TUN Ultrasonic Tip
00850440008919TUN Ultrasonic Tip
00850440008780TUN Ultrasonic Tip
00850440008773TUN Ultrasonic Tip
00850440008766TUN Ultrasonic Tip
00850440008759TUN Ultrasonic Tip
00850440008742TUN Ultrasonic Tip
00850440008735TUN Ultrasonic Tip
00850440008728TUN Ultrasonic Tip
00850440008711TUN Ultrasonic Tip
00850440008704TUN Ultrasonic Tip
00850440008698TUN Ultrasonic Tip
00850440008681TUN Ultrasonic Tip
00850440008674TUN Ultrasonic Tip
00850440008636TUN Ultrasonic Tip
00850440008629TUN Ultrasonic Tip
00850440008612TUN Ultrasonic Tip
00850440008605TUN Ultrasonic Tip
00850440008599TUN Ultrasonic Tip
00850440008452TUN Ultrasonic Tip
00850440008445TUN Ultrasonic Tip
00850440008438TUN Ultrasonic Tip
00850440008292TUN Ultrasonic Tip
00850440008278TUN Ultrasonic Tip
00850440008254TUN Ultrasonic Tip
00850440008100TUN Ultrasonic Tip
00850440008087TUN Ultrasonic Tip
00850440008063TUN Ultrasonic Tip
00850440008049TUN Ultrasonic Tip
00850440008025TUN Ultrasonic Tip
00850440008001TUN Ultrasonic Tip

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