FRICKE INTERNATIONAL, INC.

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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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (10)

Premarket Exempt

Yes

Clear

Vitacrilic® - B7159131000 Catalog Number : 9131-00

Device Description : RSI Monomer

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7159132000 Catalog Number : 9132-00

Device Description : RSI Monomer

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7159133000 Catalog Number : 9133-00

Device Description : RSI Monomer

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7159141000 Catalog Number : 9141-00

Device Description : MSI Monomer

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7159142000 Catalog Number : 9142-00

Device Description : MSI Monomer

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7159143000 Catalog Number : 9143-00

Device Description : MSI Monomer

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7159161000 Catalog Number : 9161-00

Device Description : Soft Conditioner

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7159161010 Catalog Number : 9161-01

Device Description : Soft Conditioner

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7159162000 Catalog Number : 9162-00

Device Description : Soft Conditioner

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7159163000 Catalog Number : 9163-00

Device Description : Soft Conditioner

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

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