ApexPilot

GUDID 00837699000161

ApexPilot , Apex Locator, Rechargeable Battery

Beyes Dental Canada Inc

Endodontic apex locator

• Primary Device ID: 00837699000161
• NIH Device Record Key: fc4f5dad-b0e2-4c8c-90ad-f4a054ceec01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ApexPilot
• Version Model Number: AL2040
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada Inc
• 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: false
• 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	00837699000161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181087

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [ApexPilot]

• 00837699000161: ApexPilot , Apex Locator, Rechargeable Battery
• 00837699000147: ApexPilot All-In-One, Cordless Endodontic Handpiece, Built-in Apex Locator
• 00837699000062: ApexPilot G1, Endo Motor
• 00837699000055: ApexPilot G2,Endo Motor, Connectable to Apex Locator
• 00837699000048: ApexPilot G3,Endo Motor with Built-in Apex Locator
• 00990010301252: ApexPilot G1, Endo Motor
• 00990010301245: ApexPilot G2,Endo Motor, Connectable to Apex Locator
• 00990010301238: ApexPilot G3,Endo Motor with Built-in Apex Locator
• 00990010301351: ApexPilot , Apex Locator, Rechargeable Battery
• 00990010301337: ApexPilot All-In-One, Cordless Endodontic Handpiece, Built-in Apex Locator