Harry J Bosworth Company

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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

No Yes

Clear

Bosworth Original Truliner - H66809219511 Catalog Number : 0921951

Device Description : 1 lb bulk Orig Truliner PMMA P&L Kit Pink

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth Original Truliner - H66809219521 Catalog Number : 0921952

Device Description : 1 lb bulk Orig Truliner PMMA P&L Kit Vein

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth Original Truliner - H66809219571 Catalog Number : 0921957

Device Description : 5 lb Orig Truliner PMMA Pwd Pink

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth Original Truliner - H66809219581 Catalog Number : 0921958

Device Description : 5 lb Orig Truliner PMMA Pwd Vein

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth Original Truliner - H66809219591 Catalog Number : 0921959

Device Description : 5 lb Orig Truliner PMMA Pwd Clear

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth Original Truliner - H66809219601 Catalog Number : 0921960

Device Description : Qt Orig Truliner Liquid

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219701 Catalog Number : 0921970

Device Description : 8 oz New Truliner PEMA P&L Kit Pink

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219711 Catalog Number : 0921971

Device Description : 8 oz New Truliner PEMA P&L Kit Vein

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219721 Catalog Number : 0921972

Device Description : 8 oz New Truliner P&L Kit Clear

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219731 Catalog Number : 0921973

Device Description : 8 oz New Truliner PEMA Pwd Pink

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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