Dental Engineering Lab-TFRK TFRK-SM

GUDID 00850001745055

Ultrasonic Straight Tip-EMS

DENTAL ENGINEERING LABORATORIES, LLC

Ultrasonic dental scaling/debridement system handpiece tip, endodontic

• Primary Device ID: 00850001745055
• NIH Device Record Key: 0a1ed7ff-fe8f-4976-b68b-d38a0821ec59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Engineering Lab-TFRK
• Version Model Number: TFRK-SM
• Catalog Number: TFRK-SM
• Company DUNS: 026444360
• Company Name: DENTAL ENGINEERING LABORATORIES, LLC
• Device Count: 1
• DM Exempt: true
• 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: 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	00850001745055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122501

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[00850001745055]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-10-08

On-Brand Devices [Dental Engineering Lab-TFRK]

• 00085000174500: Terauchi File Retrieval Kit w/ EMS Ultrasonic Tips
• 00850001745130: Autoclave and storage cassette
• 00850001745123: Modified Gates Glidden Bur
• 00850001745116: Micro-Trephine Bur
• 00850001745109: Micro-Explorer
• 00850001745093: Gutta Percha Removal Instrument
• 00850001745086: Loop Device for Broken Endodontic File Removal
• 00850001745079: Ultrasonic 12 o'clock Tip-EMS
• 00850001745062: Ultrasonic 6 o'clock Tip-EMS
• 00850001745055: Ultrasonic Straight Tip-EMS
• 00850001745048: Ultrasonic 12 o'clock Tip-Satelec
• 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+
• 00850001745833: Ultrasonic Straight Tip-EMS
• 00850001745826: Ultrasonic Straight Tip-Satelec