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

Cotton, Roll (EFN) (3) Varnish, Cavity (LBH) (3) Agent, Polishing, Abrasive, Oral Cavity (EJR) (2) Tray, Fluoride, Disposable (KMT) (2)

Premarket Exempt

No Yes

Clear

Disposable Fluoride Tray Medium - 00310866001456 Catalog Number : 23705

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

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : KMT

Prescription Use : No

Device Count : 100

Disposable Fluoride Trays Large - 00310866001463 Catalog Number : 23710

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

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : KMT

Prescription Use : No

Device Count : 100

Isolator Disposable Cotton Roll Holder 50 Pack - 00310866001470 Catalog Number : 28-100

Device Description : Plastic disposable cotton roll holder 50 pack.Each clamp firmly holds two cotton Plastic disposable cotton roll holder 50 pack.Each clamp firmly holds two cotton rolls, sizes 1,2 & 3.Provides a dry field without restricting access or visibility

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EFN

Prescription Use : No

Device Count : 50

Isolator Disposable Cotton Roll Holder 10 Pack - 00310866001487 Catalog Number : 28110

Device Description : Plastic disposable cotton roll holder 10 pack.Each clamp firmly holds two cotton Plastic disposable cotton roll holder 10 pack.Each clamp firmly holds two cotton rolls, sizes 1,2 & 3.Provides a dry field without restricting access or visibility

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EFN

Prescription Use : No

Device Count : 10

Radent Prophy Paste Coarse Grit Bubblegum Flavor Jar - 00310866001494 Catalog Number : 13655

Device Description : Prophy Paste with fluoride ion content; Coarse grit, bubblegum flavor, 12oz jar

Device Class : 1

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 1

Isolator Disposable Cotton Roll Holder 100 pack - 00310866001555 Catalog Number : 18600

Device Description : Plastic disposable cotton roll holder 100 pack.Each clamp firmly holds two cotto Plastic disposable cotton roll holder 100 pack.Each clamp firmly holds two cotton rolls, sizes 1,2 & 3.Provides a dry field without restricting access or visibility

Device Class :

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EFN

Prescription Use : No

Device Count : 100

Fluorilaq Squeeze Varnish Bubblegum - 00310866001562 Catalog Number : 10420

Device Description : Fluorilaq Squeeze Bubblegum with 5% Sodium Fluoride Varnish, 9.5 mL squeezable bottlev

Device Class : 2

Duns Number: 009260217

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Fluorilaq Squeeze Varnish Salted Caramel - 00310866001579 Catalog Number : 10425

Device Description : Fluorilaq Squeeze Salted Caramel with 5% Sodium Fluoride Varnish, 9.5 mL squeezable bottle

Device Class : 2

Duns Number: 009260217

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Fluorilaq Squeeze Varnish Fresh Mint - 00310866001586 Catalog Number : 10435

Device Description : Fluorilaq Squeeze Fresh Mint with 5 % Sodium Fluoride Varnish, 9.5 mL squeezable bottle

Device Class : 2

Duns Number: 009260217

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Radent Prophy Paste Medium Grit Bubblegum Non Fluoride Jar - 00310866001616 Catalog Number : 13500

Device Description : Prophy Paste without Sodium Fluoride; medium grit, bubblegum flavor, 12oz jar

Device Class : 1

Duns Number: 009260217

Premarket Exempt : No

Product Code : EJR

Prescription Use : No

Device Count : 1

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