Accurator

GUDID 00837699000130

Accurator A1

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 Endodontic apex locator 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