BIOFUNCTIONAL MATERIALS LLC

BIOFUNCTIONAL MATERIALS LLC

Address:1181 S Rogers Circle, #32,Boca Raton,FL,33487,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

Accessories, Implant, Dental, Endosseous (NDP) (10)

Premarket Exempt

Yes

Clear

ZANTEX - D916AR011 Catalog Number : AR01

Device Description : ZANTEX METAL-FREE SUPRASTRUCTURE ARCH CONFIGURATION COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ZANTEX - D916DC010 Catalog Number : DC01

Device Description : ZANTEX METAL-FREE SUPRASTRUCTURE DISK CONFIGURATION COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ZANTEX - D916DC01141 Catalog Number : DC01-14

Device Description : DISK CONFIGURATION DIA98X14MM, COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ZANTEX - D916DC01161 Catalog Number : DC01-16

Device Description : DISK CONFIGURATION DIA98X16MM, COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ZANTEX - D916DC01171 Catalog Number : DC01-17

Device Description : DISK CONFIGURATION DIA98X17MM, COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ZANTEX - D916DC02101 Catalog Number : DC02-10

Device Description : DISK CONFIGURATION DIA98X10MM, TRIANGULAR, COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ZANTEX - D916DC02141 Catalog Number : DC02-14

Device Description : DISK CONFIGURATION DIA98X14MM, TRIANGULAR, COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ZANTEX - D916DC02161 Catalog Number : DC02-16

Device Description : DISK CONFIGURATION DIA98X16MM, TRIANGULAR, COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ZANTEX - D916DC03141 Catalog Number : DC03-14

Device Description : DISK CONFIGURATION DIA95X14MM, NOTCHES, COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ZANTEX - D916DC03161 Catalog Number : DC03-16

Device Description : DISK CONFIGURATION DIA95X16MM, NOTCHES, COMPOSITE MATERIAL

Device Class : 1

Duns Number: 117102295

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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