Accurator

GUDID 00837699000130

Accurator A1

Beyes Dental Canada Inc

Endodontic apex locator

• Primary Device ID: 00837699000130
• NIH Device Record Key: 116cda65-7cc6-439c-a511-2b76c77354a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accurator
• Version Model Number: AL2010
• 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	00837699000130 [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: 2022-10-17
• Device Publish Date: 2022-10-07

On-Brand Devices [Accurator]

• 00837699000031: Accurator A2, Apex Locator, compatible with G2 Endo Motor
• 00837699000130: Accurator A1
• 00990010301221: Accurator A2, Apex Locator, compatible with G2 Endo Motor
• 00990010301320: Accurator A1