EndoPilot D-Pack² handpiece 109 0151-04

GUDID 04260482991166

Obturation handpiece D-Pack² for EndoPilot

Schlumbohm GmbH & Co. KG

Endodontic obturation system
Primary Device ID04260482991166
NIH Device Record Keyf7d2efbc-99d3-4cfb-ace5-f0052aaa3861
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoPilot D-Pack² handpiece
Version Model Numberv04
Catalog Number109 0151-04
Company DUNS343831731
Company NameSchlumbohm GmbH & Co. KG
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
GS104260482991166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKRPlugger, Root Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


[04260482991166]

High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-05
Device Publish Date2025-01-28

Devices Manufactured by Schlumbohm GmbH & Co. KG

04260482991166 - EndoPilot D-Pack² handpiece2025-02-05Obturation handpiece D-Pack² for EndoPilot
04260482991166 - EndoPilot D-Pack² handpiece2025-02-05 Obturation handpiece D-Pack² for EndoPilot
04260482991173 - EndoPilot² expansion DownPack²2025-02-05 EndoPilot DownPack expansion set consist of: D-Pack² handpiece, with LED-indicator, Heating-tip size: fine, EQV and a D-Pack/Ba
04260482990824 - Extension set ultrasonic for EndoPilot2022-09-05 Extension set ultrasonic for EndoPilot²: consisting of: Ultrasonic module, Ultrasonic handpiece Newtron/ Satelec, Ultrasonic ha
04260482991128 - EndoPilot Obtura set2021-10-22 EndoPilot Obtura expansion set consist of: 1x BackFill Gun Obtura, 1x Obtura Needle Lock Nut, 4x Heat Insulator, 5x Gun-Needl
04260482990190 - EndoPilot D-Pack2021-09-20 Downpack (D-Pack) handpiece for EndoPilot
04260482991135 - EndoPilot DownPack expansion set2021-09-20 EndoPilot DownPack expansion set consist of: D-Pack handpiece, with LED-indicator, Heating-tip size: fine and a D-Pack/Backfil
04260482990084 - EndoPilot Motor2021-06-10 EndoPilot Motor with ISO-E standard; LED-indicator and Apex-contact
04260482990602 - EndoPIlot wireless-footswitch, single2021-06-10 EndoPIlot wireless-footswitch, single

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