NOVABONE PRODUCTS, LLC

Address:13510 NW US Highway 441,ALACHUA,FL,32615,US

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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

Filler, Bone Void, Calcium Compound (MQV) (6) Bone Grafting Material, Synthetic (LYC) (4)

Premarket Exempt

Clear

Dental Putty Cartridge 2 x 1.0cc - 00813909010748 Catalog Number : NA3621

Device Description : Synthetic bone void filler for dental applications

Device Class :

Duns Number: 828813290

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 2

Dental Putty Cartridge 4 x 0.5cc - 00813909010755 Catalog Number : NA3640

Device Description : Synthetic bone void filler for dental applications

Device Class :

Duns Number: 828813290

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 4

Dental Mini Cartridge Dispenser - 00813909010762 Catalog Number : NA4600

Device Description : Dispenser used with Synthetic bone void filler for dental applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

Dental Putty Mini Cartridge 4 x 0.25cc - 00813909010779 Catalog Number : NA4640

Device Description : Synthetic bone void filler for dental applications

Device Class :

Duns Number: 828813290

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 4

MacroFORM Bioactive Packable Graft 5.0cc - 00813909010786 Catalog Number : NB0305

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

MacroFORM Bioactive Packable Graft 10.0cc - 00813909010793 Catalog Number : NB0310

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

MacroFORM Bioactive Packable Graft 15.0cc - 00813909010809 Catalog Number : NB0315

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

MacroFORM Bioactive Packable Graft 5.0cc - 00813909010816 Catalog Number : NB0399

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Putty 2.5cc - 00813909010823 Catalog Number : NB0602

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Putty 5.0cc - 00813909010830 Catalog Number : NB0605

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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