ApexPilot

GUDID 00837699000161

ApexPilot , Apex Locator, Rechargeable Battery

Beyes Dental Canada Inc

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: 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