Dental Engineering Lab-TFRK TFRK-GPR

GUDID 00850001745093

Gutta Percha Removal Instrument

DENTAL ENGINEERING LABORATORIES, LLC

Manual endodontic spreader Manual endodontic filling material spreader Manual endodontic filling material spreader Manual endodontic filling material spreader Manual endodontic filling material spreader Manual endodontic filling material spreader Manual endodontic filling material spreader Manual endodontic filling material spreader
Primary Device ID00850001745093
NIH Device Record Key0c673d23-110d-4bad-be44-467d45c93268
Commercial Distribution StatusIn Commercial Distribution
Brand NameDental Engineering Lab-TFRK
Version Model NumberTFRK-GPR
Catalog NumberTFRK-GPR
Company DUNS026444360
Company NameDENTAL ENGINEERING LABORATORIES, LLC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-805-963-2118
Emailinfo@delengineeringlab.com
Phone1-805-963-2118
Emailinfo@delengineeringlab.com
Phone1-805-963-2118
Emailinfo@delengineeringlab.com
Phone1-805-963-2118
Emailinfo@delengineeringlab.com
Phone1-805-963-2118
Emailinfo@delengineeringlab.com
Phone1-805-963-2118
Emailinfo@delengineeringlab.com
Phone1-805-963-2118
Emailinfo@delengineeringlab.com
Phone1-805-963-2118
Emailinfo@delengineeringlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001745093 [Primary]

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850001745093]

Moist Heat or Steam Sterilization

[00850001745093]

Moist Heat or Steam Sterilization

[00850001745093]

Moist Heat or Steam Sterilization

[00850001745093]

Moist Heat or Steam Sterilization

[00850001745093]

Moist Heat or Steam Sterilization

[00850001745093]

Moist Heat or Steam Sterilization

[00850001745093]

Moist Heat or Steam Sterilization

[00850001745093]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-08
Device Publish Date2018-10-08

On-Brand Devices [Dental Engineering Lab-TFRK]

00085000174500Terauchi File Retrieval Kit w/ EMS Ultrasonic Tips
00850001745130Autoclave and storage cassette
00850001745123Modified Gates Glidden Bur
00850001745116Micro-Trephine Bur
00850001745109Micro-Explorer
00850001745093Gutta Percha Removal Instrument
00850001745086Loop Device for Broken Endodontic File Removal
00850001745079Ultrasonic 12 o'clock Tip-EMS
00850001745062Ultrasonic 6 o'clock Tip-EMS
00850001745055Ultrasonic Straight Tip-EMS
00850001745048Ultrasonic 12 o'clock Tip-Satelec
00850001745031Ultrasonic 6 o'clock Tip-Satelec
00850001745024Ultrasonic Straight Tip-Satelec
00850001745017Terauchi File Retrieval Kit w/ Satelec Ultrasonic Tips
00850001745000Terauchi File Retrieval Kit w/ EMS Ultrasonic Tips
00850001745611Loop Device for Broken Endodontic File Removal
00850001745635The File Retrieval Kit w/ EMS Ultrasonic Tips and Loop+
00850001745628The File Retrieval Kit w/ Satelec Ultrasonic Tips and Loop+
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