Spident Co., Ltd.

Address:312, 151B-6L NAMDONGGONGDAN,INCHEON 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

Material, Tooth Shade, Resin (EBF) (9) Material, Impression (ELW) (1)

Premarket Exempt

No Yes

Clear

EsFlow A1 Syringe - 08809262954715 Catalog Number : 101-0801

Device Description : Nano-hybrid Flowable composite resin for posterior and anterior restorations.

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

EsFlow A2 Syringe - 08809262954722 Catalog Number : 101-0802

Device Description : Nano-hybrid Flowable composite resin for posterior and anterior restorations.

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

EsFlow A3 Syringe - 08809262954739 Catalog Number : 101-0803

Device Description : Nano-hybrid Flowable composite resin for posterior and anterior restorations.

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

EsFlow A3.5 Syringe - 08809262954746 Catalog Number : 101-0804

Device Description : Nano-hybrid Flowable composite resin for posterior and anterior restorations.

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

EsFlow B2 Syringe - 08809262954760 Catalog Number : 101-0805

Device Description : Nano-hybrid Flowable composite resin for posterior and anterior restorations.

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Core It Yellow - 08809262954838 Catalog Number : 101-0301

Device Description : Radiopaque, dual cured composite core build up material in tooth shade

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Core It Blue - 08809262954845 Catalog Number : 101-0302

Device Description : Radiopaque, dual cured composite core build up material in blue shade

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Core It White - 08809262954869 Catalog Number : 101-0303

Device Description : Radiopaque, dual cured composite core build up material in white shade

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

I-SIL Heavy Body Regular Set - 08809262955033 Catalog Number :

Device Description : Vinyl Polysiloxane Impression Material

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

EsCom100 A4 Syringe - 08809262955200 Catalog Number : 101-0705

Device Description : Nano-hybrid universal composite resin for posterior and anterior restorations.

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

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