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® - B71501054006P0 Catalog Number : 01054-006P

Device Description : Simpson Fibered

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501056600P0 Catalog Number : 01056-600P

Device Description : Deep Purple Fibered

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501062001P0 Catalog Number : 01062-001P

Device Description : Special Fibered #10

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501062006P0 Catalog Number : 01062-006P

Device Description : Special Fibered #10

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71501062025P0 Catalog Number : 01062-025P

Device Description : Special Fibered #10

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B7150202020 Catalog Number : 0202-02

Device Description : Ortho Orange Self Curing

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71502024001P0 Catalog Number : 02024-001P

Device Description : Getz Bros Char

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71503001006P0 Catalog Number : 03001-006P

Device Description : #1 Extra Fine LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71503015006P0 Catalog Number : 03015-006P

Device Description : SPECIAL FIBERED #4 LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71503016006P0 Catalog Number : 03016-006P

Device Description : SPECIAL FIBERED #5 LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

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