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) (5) Point, Paper, Endodontic (EKN) (5)

Premarket Exempt

No Yes

Clear

F360 - 18809264298050 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 25, 100/PK, mm marked, SB, 25.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

F360 - 18809264298067 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 35, 100/PK, mm marked, SB, 35.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

F360 - 18809264298074 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

F360 - 18809264298081 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 55, 100/PK, mm marked, SB, 55.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

F360 - 18809264298098 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 25,35,45,55, 60/PK, mm marked, SB, 25,35,45,55/.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 60

F6 SkyTaper - 18809264298104 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

F6 SkyTaper - 18809264298111 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

F6 SkyTaper - 18809264298128 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

F6 SkyTaper - 18809264298135 Catalog Number :

Device Description : Gutta Percha Points Taper .06, Size 35, 100/PK, mm marked, SB, 35.06

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

F6 SkyTaper - 18809264298142 Catalog Number :

Device Description : Gutta Percha Points Taper .06, Size 40, 100/PK, mm marked, SB, 40.06

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

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