AUGMA BIOMATERIALS LTD

Address:Alon Hatavor 20 St. P.O.Box 3089,Caesarea Southern Industrial Park Northern,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

Bone Grafting Material, Synthetic (LYC) (5) Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic (MGQ) (1) Oral Wound Dressing (OLR) (1)

Premarket Exempt

Clear

3D Bond - 07290014838000 Catalog Number :

Device Description : ‎3D Bond is a synthetic, osteoconductive, ‎bioresorbable graft binder cement co ‎3D Bond is a synthetic, osteoconductive, ‎bioresorbable graft binder cement composed ‎of biphasic Calcium Sulfate in a granulated ‎powder form. 3D Bond functions as a ‎scaffold for bone regeneration in dental ‎procedures, and is intended to fill, augment or ‎reconstruct bony defects in the oral and ‎maxillofacial region.‎

Device Class : 2

Duns Number: 533432352

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

3D Bond - 07290014838017 Catalog Number :

Device Class : 2

Duns Number: 533432352

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

Bond Apatite - 07290014838024 Catalog Number :

Device Description : Bond Apatite® is a synthetic, ‎osteoconductive, composite graft cement ‎composed Bond Apatite® is a synthetic, ‎osteoconductive, composite graft cement ‎composed of biphasic calcium sulfate and ‎hydroxyapatite granules. Bond Apatite® ‎functions as a scaffold for bone regeneration ‎in dental procedures, and is intended to fill, ‎augment or reconstruct bony defects in the ‎oral and maxillofacial region.‎

Device Class : 2

Duns Number: 533432352

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

Bond Apatite - 07290014838031 Catalog Number :

Device Class : 2

Duns Number: 533432352

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

3D Bond+ - 07290014838055 Catalog Number :

Device Class : 2

Duns Number: 533432352

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

Augma Shield - 08800026800347 Catalog Number :

Device Class : U

Duns Number: 533432352

Premarket Exempt : No

Product Code : MGQ, OLR

Prescription Use : No

Device Count : 1

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