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® - B71503021025P0 Catalog Number : 03021-025P

Device Description : Special Fibered #55 LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71503023001P0 Catalog Number : 03023-001P

Device Description : Special Grain #3 Short Fibered LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71503023006P0 Catalog Number : 03023-006P

Device Description : Special Grain #3 Short Fibered LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71503023025P0 Catalog Number : 03023-025P

Device Description : Special Grain #3 Short Fibered LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71503026025P0 Catalog Number : 03026-025P

Device Description : #400 Special Short Fibered LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71504003001P0 Catalog Number : 04003-001P

Device Description : #200 Light LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71504003006P0 Catalog Number : 04003-006P

Device Description : #200 Light LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Vitacrilic® - B71504004006P0 Catalog Number : 04004-006P

Device Description : #200 Special Dark LW

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B71504019001P0 Catalog Number : 04019-001P

Device Description : #200 LT SF HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B71504019006P0 Catalog Number : 04019-006P

Device Description : #200 LT SF HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

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