EndoPilot Apex measuring cable with plug 109 2312

GUDID 04260482990589

Apex measuring cable with plug

Schlumbohm GmbH & Co. KG

Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator

• Primary Device ID: 04260482990589
• NIH Device Record Key: 3140ee2f-dea4-4e39-ab35-35adda21cac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoPilot Apex measuring cable with plug
• Version Model Number: EDP2
• Catalog Number: 109 2312
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260482990589 [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

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

[04260482990589]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-08
• Device Publish Date: 2021-05-31

Devices Manufactured by Schlumbohm GmbH & Co. KG

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• 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