SURE DENT CORPORATION

Address:#809, 52, SAGIMAKGOL-RO,SEONGNAM-SI Gyeonggi,KR

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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

Gutta-Percha (EKM) (8) Point, Paper, Endodontic (EKN) (2)

Premarket Exempt

No Yes

Clear

Procodile - 18809264297657 Catalog Number :

Device Description : Gutta Percha Points Taper .04, Size 45, 100/PK, mm marked, SB, 45.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297664 Catalog Number :

Device Description : Gutta Percha Points Taper .04, Size 50, 100/PK, mm marked, SB, 50.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297671 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .05, Size 35, 100/PK, mm marked, SB, 35.05

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297688 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .05, Size 40, 100/PK, mm marked, SB, 40.05

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297695 Catalog Number :

Device Description : Gutta Percha Points Taper .06, Size 20, 100/PK, mm marked, SB, 20.06

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297701 Catalog Number :

Device Description : Gutta Percha Points Taper .06, Size 25, 100/PK, mm marked, SB, 25.06

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297718 Catalog Number :

Device Description : Gutta Percha Points Taper .06, Size 30, 100/PK, mm marked, SB, 30.06

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297725 Catalog Number :

Device Description : Gutta Percha Points Taper .06,.05, Size 25-30,35-40, 60/PK, mm marked, SB, 25-30 Gutta Percha Points Taper .06,.05, Size 25-30,35-40, 60/PK, mm marked, SB, 25-30/.06,35-40/.05

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Procodile - 18809264297732 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 45, 100/PK, mm marked, SB, 45.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297749 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 50, 100/PK, mm marked, SB, 50.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

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