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® - B71501042006P0 Catalog Number : 01042-006P

Device Description : Special Fibered # 5 Deep

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501042025P0 Catalog Number : 01042-025P

Device Description : Special Fibered #5 Deep

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501043001P0 Catalog Number : 01043-001P

Device Description : Special Fibered #51

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501043006P0 Catalog Number : 01043-006P

Device Description : Special Fibered #51

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B715010430480 Catalog Number : 01043-048

Device Description : Special Fibered #51

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501044006P0 Catalog Number : 01044-006P

Device Description : Special Fibered #52

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501045001P0 Catalog Number : 01045-001P

Device Description : Special Fibered #7

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501045006P0 Catalog Number : 01045-006P

Device Description : Special Fibered #7

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501053006P0 Catalog Number : 01053-006P

Device Description : Fibered XL2

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501053025P0 Catalog Number : 01053-025P

Device Description : Fibered XL2

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

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