SURE DENT CORPORATION

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) (10)

Premarket Exempt

No Yes

Clear

Minikut - 08800069202535 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .03, Size 15, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Minikut - 08800069202542 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .03, Size 15-40, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Minikut - 08800069202559 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .03, Size 20, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Minikut - 08800069202566 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .03, Size 25, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Minikut - 08800069202573 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .03, Size 30, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Minikut - 08800069202580 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .03, Size 35, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Minikut - 08800069202597 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .03, Size 40, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Minikut - 08800069202603 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .03, Size 45, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Minikut - 08800069202610 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .05, Size 15, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

Minikut - 08800069202627 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .05, Size 15-40, 60/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 60

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