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) Agent, Tooth Bonding, Resin (KLE) (1)

Premarket Exempt

No Yes

Clear

EsCom 100 A1 Syringe - 08809262955217 Catalog Number : 101-0701

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

EsCom100 A2 Syringe - 08809262955224 Catalog Number : 101-0702

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

EsCom100 A3 Syringe - 08809262955231 Catalog Number : 101-0703

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

EsCom100 A3.5 Syringe - 08809262955248 Catalog Number : 101-0704

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

EsCom 100 B1 Syringe - 08809262955262 Catalog Number : 101-0709

Device Class : 2

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

EsCom100 B2 Syringe - 08809262955279 Catalog Number : 101-0708

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

EsCom 100 C2 Syringe - 08809262955293 Catalog Number : 101-0710

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

EsCom 100 TW Syringe - 08809262955323 Catalog Number : 101-0711

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

EsBond - 08809262955415 Catalog Number : 101-0501

Device Description : 5th Generation Bonding. Light Cured, single bottle application bonding system.

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

EsBond Activator - 08809262955439 Catalog Number : 101-0502

Device Class :

Duns Number: 689370711

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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