PASCAL COMPANY, 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

Agent, Polishing, Abrasive, Oral Cavity (EJR) (6) Cup, Prophylaxis (EHK) (3) Tray, Fluoride, Disposable (KMT) (1)

Premarket Exempt

No Yes

Clear

Radent Prophy Paste, Medium, Grit Mint Jar - 00310866001319 Catalog Number : 13600

Device Description : Prophy Paste with fluoride ion content of 1.23%; Medium grit, mint flavor, 12 oz jar

Device Class : 1

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 1

Radent Prophy Paste Coarse Grit Mint Flavor Jar - 00310866001326 Catalog Number : 13605

Device Description : Prophy Paste with fluoride ion content of 1.23%; Coarse grit, mint flavor, 12 oz jar

Device Class : 1

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 1

Radent Prophy Paste, Medium Grit, Bubblegum Flavor Jar - 00310866001333 Catalog Number : 13650

Device Description : Prophy Paste with fluoride ion content of 1.23%; medium grit, bubble gum flavor, 12 oz jar

Device Class : 1

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 1

Radent Prophy Paste Medium Grit Cherry Jar - 00310866001340 Catalog Number : 13700

Device Description : Prophy Paste with fluoride ion content of 1.23%; medium grit, cherry flavor, 12 oz jar

Device Class : 1

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 1

Radent Prophy Paste Coarse Grit Cherry Jar - 00310866001357 Catalog Number : 13705

Device Description : Prophy Paste with fluoride ion content of 1.23%; coarse grit, cherry flavor, 12oz jar

Device Class : 1

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 1

Radent Prophy Paste Medium Grit Strawberry Jar - 00310866001364 Catalog Number : 13800

Device Description : Prophy Paste with fluoride ion content of 1,23%; medium grit, strawberry flavor. Prophy Paste with fluoride ion content of 1,23%; medium grit, strawberry flavor. 12 oz jar.

Device Class : 1

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 1

Prophy Angle - Screw On - 00310866001418 Catalog Number : 22100

Device Description : Autoclavable prophy angle, screw on

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EHK

Prescription Use : No

Device Count : 1

Prophy Angle - Snap on - 00310866001425 Catalog Number : 22150

Device Description : Autoclavable prophy angle, snap on

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EHK

Prescription Use : No

Device Count : 1

Contra Angle - 00310866001432 Catalog Number : 22200

Device Description : Autoclavable prophy angle, standare "U"

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EHK

Prescription Use : No

Device Count : 1

Disposable Fluoride Tray Small - 00310866001449 Catalog Number : 23700

Device Description : Disposable fluoride trays for administering fluoride gel treatment, small 100 trays

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : KMT

Prescription Use : No

Device Count : 100

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