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

Minikut - 08800069202832 Catalog Number :

Device Description : Absorbent Paper Points Taper .05, Size 40, 100/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

Minikut - 08800069202849 Catalog Number :

Device Description : Absorbent Paper Points Taper .05, Size 45, 100/PK, mm marked, SB

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

Bassi - 08800069202856 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

Bassi - 08800069202863 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

Bassi - 08800069202870 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

Bassi - 08800069202887 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

Bassi - 08800069202894 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

Bassi - 08800069202900 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .04, 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

Bassi - 08800069202917 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .04, 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

Bassi - 08800069202924 Catalog Number :

Device Description : Bio Gutta Percha Points Taper .05, 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

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