DENTAL ENGINEERING LABORATORIES, LLC

Address:315 Bollay Drive,Goleta,CA,93117,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Scaler, Ultrasonic (ELC) (6) Endodontic Kit (NYD) (2) Instruments, Dental Hand (DZN) (2)

Premarket Exempt

No Yes

Clear

Dental Engineering Lab-TFRK - 00850001745000 Catalog Number : TFRK-EMS

Device Description : Terauchi File Retrieval Kit w/ EMS Ultrasonic Tips

Device Class : 2

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : NYD

Prescription Use : Yes

Device Count : 1

Dental Engineering Lab-TFRK - 00850001745017 Catalog Number : TFRK-SET

Device Description : Terauchi File Retrieval Kit w/ Satelec Ultrasonic Tips

Device Class : 2

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : NYD

Prescription Use : Yes

Device Count : 1

Dental Engineering Lab-TFRK - 00850001745024 Catalog Number : TFRK-S

Device Description : Ultrasonic Straight Tip-Satelec

Device Class : 2

Duns Number: 026444360

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Dental Engineering Lab-TFRK - 00850001745031 Catalog Number : TFRK-6

Device Description : Ultrasonic 6 o'clock Tip-Satelec

Device Class : 2

Duns Number: 026444360

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Dental Engineering Lab-TFRK - 00850001745048 Catalog Number : TFRK-12

Device Description : Ultrasonic 12 o'clock Tip-Satelec

Device Class : 2

Duns Number: 026444360

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Dental Engineering Lab-TFRK - 00850001745055 Catalog Number : TFRK-SM

Device Description : Ultrasonic Straight Tip-EMS

Device Class : 2

Duns Number: 026444360

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Dental Engineering Lab-TFRK - 00850001745062 Catalog Number : TFRK-6M

Device Description : Ultrasonic 6 o'clock Tip-EMS

Device Class : 2

Duns Number: 026444360

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Dental Engineering Lab-TFRK - 00850001745079 Catalog Number : TFRK-12M

Device Description : Ultrasonic 12 o'clock Tip-EMS

Device Class : 2

Duns Number: 026444360

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Dental Engineering Lab-TFRK - 00850001745086 Catalog Number : TFRK-L

Device Description : Loop Device for Broken Endodontic File Removal

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : Yes

Device Count : 1

Dental Engineering Lab-TFRK - 00850001745093 Catalog Number : TFRK-GPR

Device Description : Gutta Percha Removal Instrument

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : Yes

Device Count : 1

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