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 - 18809264297954 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 25, 200/PK, mm marked, CP, 25.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

F360 - 18809264297961 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 35, 200/PK, mm marked, CP, 35.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

F360 - 18809264297978 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 45, 200/PK, mm marked, CP, 45.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

F360 - 18809264297985 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 55, 200/PK, mm marked, CP, 55.04

Device Class :

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

F360 - 18809264297992 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 25,35,45,55, 200/PK, mm marked, CP, 25,35,45,55/.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

F360 - 18809264298005 Catalog Number :

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

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

F360 - 18809264298012 Catalog Number :

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

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

F360 - 18809264298029 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

F360 - 18809264298036 Catalog Number :

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

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

F360 - 18809264298043 Catalog Number :

Device Description : Gutta Percha 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 : EKM

Prescription Use : Yes

Device Count : 60

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