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

File, Pulp Canal, Endodontic (EKS) (10)

Premarket Exempt

No Yes

Clear

MiniKut - 00850001745413 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .25/.05, 21mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

MiniKut - 00850001745420 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .25/.05, 25mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

MiniKut - 00850001745437 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .25/.05, 31mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

MiniKut - 00850001745444 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .30/.05, 21mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

MiniKut - 00850001745451 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .30/.05, 25mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

MiniKut - 00850001745468 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .30/.05, 31mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

MiniKut - 00850001745475 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .35/.05, 21mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

MiniKut - 00850001745482 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .35/.05, 25mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

MiniKut - 00850001745499 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .35/.05, 31mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

MiniKut - 00850001745505 Catalog Number :

Device Description : MiniKut Rotary NiTi Endodontic Files .40/.05, 21mm 6 Pack

Device Class : 1

Duns Number: 026444360

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 1

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