| Primary Device ID | 00085000174500 |
| NIH Device Record Key | 43291b16-b3c7-43a6-80a0-6ccfdd1fb6e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dental Engineering Lab-TFRK |
| Version Model Number | TFRK-EMS |
| Catalog Number | TFRK-EMS |
| 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 | true |
| 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 |
| Phone | 1-805-963-2118 |
| info@delengineeringlab.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085000174500 [Primary] |
| NYD | Endodontic Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00085000174500]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2018-10-08 |
| 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 |