FRICKE INTERNATIONAL, INC.

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® - B71501003006P0 Catalog Number : 01003-006P

Device Description : #200 Special Dark SF

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7150101020 Catalog Number : 0101-02

Device Description : Ortho Red Self Curing

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501017006P0 Catalog Number : 01017-006P

Device Description : Extra Fine

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501018001P0 Catalog Number : 01018-001P

Device Description : FT #200

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501018006P0 Catalog Number : 01018-006P

Device Description : FT #200

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501030025P0 Catalog Number : 01030-025P

Device Description : Piedmont Plain

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501033006P0 Catalog Number : 01033-006P

Device Description : Regular Fibered

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501033025P0 Catalog Number : 01033-025P

Device Description : Regular Fibered

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501034001P0 Catalog Number : 01034-001P

Device Description : Special Fibered #1

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501034006P0 Catalog Number : 01034-006P

Device Description : Special Fibered #1

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

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