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

Instruments, Dental Hand (DZN) (8) Varnish, Cavity (LBH) (2)

Premarket Exempt

No Yes

Clear

Waterpik Ultra Thin & Clear Varnish - D686200306763 Catalog Number : 20030676

Device Description : 5% Sodium Fluoride, Strawberry flavor

Device Class : 2

Duns Number: 001804074

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 30

Waterpik Ultra Thin & Clear Varnish - D686200306773 Catalog Number : 20030677

Device Description : 5% Sodium Fluoride, Mint flavor

Device Class : 2

Duns Number: 001804074

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 30

Waterpik Original Tofflemire Matrix Bands - D6863457703 Catalog Number : 34577-0

Device Description : No. 1 Adult Universal

Device Class :

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 36

Waterpik Original Tofflemire Matrix Bands - D6863457893 Catalog Number : 34578-9

Device Description : No. 1 Adult Universal

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 36

Waterpik Original Tofflemire Matrix Bands - D6863457973 Catalog Number : 34579-7

Device Description : No. 2 Adult MOD Wide

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 36

Waterpik Original Tofflemire Matrix Bands - D6863458003 Catalog Number : 34580-0

Device Description : No. 2 Adult MOD Wide

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 36

Waterpik Original Tofflemire Matrix Bands - D6863458263 Catalog Number : 34582-6

Device Description : No. 3 Adult MOD Narrow

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 36

Waterpik Original Tofflemire Matrix Bands - D6863458423 Catalog Number : 34584-2

Device Description : No. 13 Pedo Universal

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 36

Waterpik Original Tofflemire Matrix Bands - D6863458503 Catalog Number : 34585-0

Device Description : No. 13 Pedo Universal

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 36

Waterpik Original Tofflemire “Dead Soft” Matrix Bands - D6863460363 Catalog Number : 34603-6

Device Description : No. 1 Adult Universal

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 36

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