Extension set ultrasonic for EndoPilot 110 3002

GUDID 04260482990824

Extension set ultrasonic for EndoPilot²: consisting of: Ultrasonic module, Ultrasonic handpiece Newtron/ Satelec, Ultrasonic handpiece cable, Satelec, (aprox. 180cm), Rinsing adapter, Universal wrench, and a half base plate.

Schlumbohm GmbH & Co. KG

Ultrasonic dental scaling/debridement system

• Primary Device ID: 04260482990824
• NIH Device Record Key: a1ad9b2b-3af2-4529-a07d-da752896d987
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extension set ultrasonic for EndoPilot
• Version Model Number: v01
• Catalog Number: 110 3002
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260482990824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202906

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04260482990824]

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: 2022-09-05
• Device Publish Date: 2022-08-26

Devices Manufactured by Schlumbohm GmbH & Co. KG

• 04260482990824 - Extension set ultrasonic for EndoPilot: 2022-09-05Extension set ultrasonic for EndoPilot²: consisting of: Ultrasonic module, Ultrasonic handpiece Newtron/ Satelec, Ultrasonic handpiece cable, Satelec, (aprox. 180cm), Rinsing adapter, Universal wrench, and a half base plate.
• 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