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

Point, Paper, Endodontic (EKN) (10)

Premarket Exempt

No Yes

Clear

Procodile - 18809264297756 Catalog Number :

Device Description : Absorbent Paper Points Taper .05, Size 35, 100/PK, mm marked, SB, 35.05

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297763 Catalog Number :

Device Description : Absorbent Paper Points Taper .05, Size 40, 100/PK, mm marked, SB, 40.05

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297770 Catalog Number :

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

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297787 Catalog Number :

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

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297794 Catalog Number :

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

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 100

Procodile - 18809264297800 Catalog Number :

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

Prescription Use : Yes

Device Count : 60

Procodile - 18809264297817 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

Procodile - 18809264297824 Catalog Number :

Device Description : Absorbent Paper Points Taper .04, Size 50, 200/PK, mm marked, CP, 50.04

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

Procodile - 18809264297831 Catalog Number :

Device Description : Absorbent Paper Points Taper .05, Size 35, 200/PK, mm marked, CP, 35.05

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

Procodile - 18809264297848 Catalog Number :

Device Description : Absorbent Paper Points Taper .05, Size 40, 200/PK, mm marked, CP, 40.05

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

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