SILMET LTD

Address:12 HASADNA,OR YEHUDA Tel Aviv,IL

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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) (5) Agent, Tooth Bonding, Resin (KLE) (3) Cement, Dental (EMA) (2)

Premarket Exempt

Clear

ProGlass - 07290016787429 Catalog Number : 17KT11

Device Description : Dental Glass Ionomer Cement

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

ProGlass - 07290016787436 Catalog Number : 17KT12

Device Description : Dental Glass Ionomer Cement

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

ProEtch - 07290016787450 Catalog Number : 190100

Device Description : Dental Adhesive

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

ProEtch - 07290016787467 Catalog Number : 190124

Device Description : Dental Adhesive

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

ProEtch - 07290016787474 Catalog Number : 190160

Device Description : Dental Adhesive

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

ProFil Flow - 07290016787498 Catalog Number : SM-163A01

Device Description : Dental Composite Restorative

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

ProFil Flow - 07290016787504 Catalog Number : SM-163A02

Device Description : Dental Composite Restorative

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

ProFil Flow - 07290016787511 Catalog Number : SM-163A03

Device Description : Dental Composite Restorative

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

ProFil Flow - 07290016787528 Catalog Number : SM-163A35

Device Description : Dental Composite Restorative

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

ProFil Flow - 07290016787535 Catalog Number : SM-163B01

Device Description : Dental Composite Restorative

Device Class : 2

Duns Number: 600071344

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

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