EndoPilot Komet 110 0607

GUDID 04260482991029

EndoPilot² Komet comfort consist of: Control Unit: EndoPilot² unit , Display: 7" TFT touch-screen (Komet) AC/DC Adapter for EndoPilot² Wireless-Footswitch, single, bluetooth Apex-cable-set Retainer for apex-cable Preparation: EndiPilot-Motor with ISO-E standard & LED-indicator, integrated apex-connection EndoPilot-contra-angle, 1:1, insulates, ISO-E standard

Schlumbohm GmbH & Co. KG

Endodontic apex locator
Primary Device ID04260482991029
NIH Device Record Key27b30387-d0a4-4ec5-a371-98beaa4c0c71
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoPilot Komet
Version Model Numbercomfort
Catalog Number110 0607
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260482991029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQYLocator, Root Apex

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04260482991029]

Moist Heat or Steam Sterilization;High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-02
Device Publish Date2021-05-25

Devices Manufactured by Schlumbohm GmbH & Co. KG

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
04260482990763 - EndoPilot Control Box, Komet2021-06-10 EndoPilot² Control Box, Komet
04260482990787 - EndoPilot power supply2021-06-10 AC/DC power supply for EndoPilot²

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