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

Cord, Retraction (MVL) (6) Agent, Polishing, Abrasive, Oral Cavity (EJR) (3) Varnish, Cavity (LBH) (1)

Premarket Exempt

No Yes

Clear

Gel Cord Clear Topical Hemostatic Gel 30g Jar - 00310866000848 Catalog Number : 15810

Device Description : 25% aluminum sulfate gel 30g jar; No color

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Gel Cord Topical Hemostatic Gel ProPack - 00310866000855 Catalog Number : 15540

Device Description : 25% aluminum sulfate gel; 25 - 0.75g syringes

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 12

Gel Cord Topical Hemostatic Gel MicroPoints - 00310866000862 Catalog Number : 15505

Device Description : 25% aluminum sulfate gel - 25 - 0.32g MicroPoint Cartridges.

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 25

Gel Cord Topical Hemostatic Gel 30g Jar - 00310866000879 Catalog Number : 15510

Device Description : 25 % Aluminum Sulfate Gel 30g Jar

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Stat Gel Topical Hemostatic Gel ProPack - 00310866000893 Catalog Number : 15740

Device Description : Topical hemostatic gel with 15.5% ferric sulfate, 12 - 0.75g syringes

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 12

Stat Gel Topical Hemostatic Gel 30g Jar - 00310866000909 Catalog Number : 15710

Device Description : Topical hemostatic gel with 15.5% ferric sulfate, 30g jar

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Fluorilaq Varnish Bubblegum - 00310866001104 Catalog Number : 10400

Device Description : Fluorilaq Bubblegum with 5% Sodium Fluoride Varnish. 10 mL tube

Device Class : 2

Duns Number: 009260217

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Radent Prophy Paste Cups, Medium, Fresh Mint - 00310866001265 Catalog Number : 13200

Device Description : Prophy Paste cups, 200 -1.23% fluoride ion with sodium phosphate, Fresh Mint fla Prophy Paste cups, 200 -1.23% fluoride ion with sodium phosphate, Fresh Mint flavor, Medium grit,

Device Class :

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 200

Radent Prophy Paste Cups, Coarst Grit, Mint Flavor - 00310866001272 Catalog Number : 13205

Device Description : Prophy Paste cups, 1.23% fluoride ion with sodium phosphate, Coarse Grit, Mint Flavor

Device Class :

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 200

Radent Prophy Paste Cups, Fine Grit, Cotton Candy for Kids - 00310866001302 Catalog Number : 13260

Device Description : Prophy Paste cups, 1.23% fluoride ion with sodium phosphate, Fine Grit, Cotton C Prophy Paste cups, 1.23% fluoride ion with sodium phosphate, Fine Grit, Cotton Candy for Kids

Device Class :

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 200

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