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 ID: 04260482991029
• NIH Device Record Key: 27b30387-d0a4-4ec5-a371-98beaa4c0c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoPilot Komet
• Version Model Number: comfort
• Catalog Number: 110 0607
• Company DUNS: 343831731
• Company Name: Schlumbohm GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260482991029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202906

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-02
• Device Publish Date: 2021-05-25

Devices Manufactured by Schlumbohm GmbH & Co. KG

• 04260482990824 - Extension set ultrasonic for EndoPilot: 2022-09-05 Extension set ultrasonic for EndoPilot²: consisting of: Ultrasonic module, Ultrasonic handpiece Newtron/ Satelec, Ultrasonic ha
• 04260482991128 - EndoPilot Obtura set: 2021-10-22 EndoPilot Obtura expansion set consist of: 1x BackFill Gun Obtura, 1x Obtura Needle Lock Nut, 4x Heat Insulator, 5x Gun-Needl
• 04260482990190 - EndoPilot D-Pack: 2021-09-20 Downpack (D-Pack) handpiece for EndoPilot
• 04260482991135 - EndoPilot DownPack expansion set: 2021-09-20 EndoPilot DownPack expansion set consist of: D-Pack handpiece, with LED-indicator, Heating-tip size: fine and a D-Pack/Backfil
• 04260482990084 - EndoPilot Motor: 2021-06-10 EndoPilot Motor with ISO-E standard; LED-indicator and Apex-contact
• 04260482990602 - EndoPIlot wireless-footswitch, single: 2021-06-10 EndoPIlot wireless-footswitch, single
• 04260482990763 - EndoPilot Control Box, Komet: 2021-06-10 EndoPilot² Control Box, Komet
• 04260482990787 - EndoPilot power supply: 2021-06-10 AC/DC power supply for EndoPilot²