Dental Engineering Lab-TFRK

GUDID 00850001745628

The File Retrieval Kit w/ Satelec Ultrasonic Tips and Loop+

DENTAL ENGINEERING LABORATORIES, LLC

Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID00850001745628
NIH Device Record Key30b8f007-559f-4ff8-a641-04a6cf10a132
Commercial Distribution StatusIn Commercial Distribution
Brand NameDental Engineering Lab-TFRK
Version Model NumberTFRK-SET+
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001745628 [Primary]

FDA Product Code

NYDEndodontic Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

[00850001745628]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-30
Device Publish Date2022-08-22

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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