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

HI-I® - B715A11P0 Catalog Number : A1-1P

Device Description : Associated #1 HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B715A1221P0 Catalog Number : A122-1P

Device Description : Associated #122 HI-I® Pour

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B715A12225P0 Catalog Number : A122-25P

Device Description : Associated #122 HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B715A1226P0 Catalog Number : A122-6P

Device Description : Associated #122 HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B715A125P0 Catalog Number : A1-25P

Device Description : Associated #1 HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B715A16P0 Catalog Number : A1-6P

Device Description : Associated #1 HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B715A225P0 Catalog Number : A2-25P

Device Description : Associated #2 HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B715A26P0 Catalog Number : A2-6P

Device Description : Associated #2 HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B715A2SC6P0 Catalog Number : A2SC-6P

Device Description : Associated #2 HI-I® Self Curing

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

HI-I® - B715A49DP1P0 Catalog Number : A49DP-1P

Device Description : Associated #49 DEEP HI-I®

Device Class : 2

Duns Number: 957630726

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

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