Dental Engineering Lab-TFRK TFRK-L

GUDID 00850001745086

Loop Device for Broken Endodontic File Removal

DENTAL ENGINEERING LABORATORIES, LLC

Endodontic file retrieval loop

• Primary Device ID: 00850001745086
• NIH Device Record Key: c44c66f9-1ede-4da3-b689-868694bc7cfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Engineering Lab-TFRK
• Version Model Number: TFRK-L
• Catalog Number: TFRK-L
• Company DUNS: 026444360
• Company Name: DENTAL ENGINEERING LABORATORIES, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: 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

Customer Support Contacts

• Phone: 1-805-963-2118
• Email: info@delengineeringlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001745086 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

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

[00850001745086]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-10-08

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• 00850001745062: Ultrasonic 6 o'clock Tip-EMS
• 00850001745055: Ultrasonic Straight Tip-EMS
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• 00850001745031: Ultrasonic 6 o'clock Tip-Satelec
• 00850001745024: Ultrasonic Straight Tip-Satelec
• 00850001745017: Terauchi File Retrieval Kit w/ Satelec Ultrasonic Tips
• 00850001745000: Terauchi File Retrieval Kit w/ EMS Ultrasonic Tips
• 00850001745611: Loop Device for Broken Endodontic File Removal
• 00850001745635: The File Retrieval Kit w/ EMS Ultrasonic Tips and Loop+
• 00850001745628: The File Retrieval Kit w/ Satelec Ultrasonic Tips and Loop+