WATER PIK, INC.

Address:1730 EAST PROSPECT RD.,FORT COLLINS,CO,80553,US

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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

Varnish, Cavity (LBH) (7) Agent, Polishing, Abrasive, Oral Cavity (EJR) (3)

Premarket Exempt

No Yes

Clear

Waterpik Prophy Paste - D686200304543 Catalog Number : 20030454

Device Description : Mint flavor, coarse grit

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : No

Device Count : 200

Waterpik Prophy Paste - D686200304553 Catalog Number : 20030455

Device Description : Melon flavor, fine grit

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : No

Device Count : 200

Waterpik Prophy Paste - D686200304563 Catalog Number : 20030456

Device Description : Mint flavor, medium grit

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : No

Device Count : 200

Waterpik Ultra Thin & Clear Varnish - D686200306693 Catalog Number : 20030669

Device Description : 5% Sodium Fluoride, Melon flavor

Device Class : 2

Duns Number: 001804074

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 100

Waterpik Ultra Thin & Clear Varnish - D686200306703 Catalog Number : 20030670

Device Description : 5% Sodium Fluoride, Bubblegum flavor

Device Class : 2

Duns Number: 001804074

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 100

Waterpik Ultra Thin & Clear Varnish - D686200306713 Catalog Number : 20030671

Device Description : 5% Sodium Fluoride, Strawberry flavor

Device Class : 2

Duns Number: 001804074

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 100

Waterpik Ultra Thin & Clear Varnish - D686200306723 Catalog Number : 20030672

Device Description : 5% Sodium Fluoride, Mint flavor

Device Class : 2

Duns Number: 001804074

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 100

Waterpik Ultra Thin & Clear Varnish - D686200306733 Catalog Number : 20030673

Device Description : 5% Sodium Fluoride, Variety Pack - 25 ea - Bubblegum, Melon, Strawberry, and Mint flavors

Device Class : 2

Duns Number: 001804074

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 100

Waterpik Ultra Thin & Clear Varnish - D686200306743 Catalog Number : 20030674

Device Description : 5% Sodium Fluoride, Melon flavor

Device Class : 2

Duns Number: 001804074

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 30

Waterpik Ultra Thin & Clear Varnish - D686200306753 Catalog Number : 20030675

Device Description : 5% Sodium Fluoride, Bubblegum flavor

Device Class : 2

Duns Number: 001804074

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 30

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