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) (5) Zinc Oxide Eugenol (EMB) (2) Cement, Dental (EMA) (1) Material, Tooth Shade, Resin (EBF) (1) Varnish, Cavity (LBH) (1)

Premarket Exempt

No Yes

Clear

Waterpik Original Tofflemire “Dead Soft” Matrix Bands - D6863460443 Catalog Number : 34604-4

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 “Dead Soft” Matrix Bands - D6863460523 Catalog Number : 34605-2

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 Getz Blue Core - D6864141839 Catalog Number : 041418-000

Device Description : Crown build-up material, single 5g syringe

Device Class : 2

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : No

Device Count : 1

Waterpik Barrier Dentin Sealant - D6864230535 Catalog Number : 042305-000

Device Description : Cavity varnish, Kit containing 15ml of sealant and 50 pipettes.

Device Class : 2

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : LBH

Prescription Use : No

Device Count : 1

Waterpik Opotow Temporary Cement - D686521173 Catalog Number : 052117-000

Device Description : Zinc oxide eugenol temporary dental cement

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : EMB

Prescription Use : No

Device Count : 1

Waterpik Opotow Trial Cement - D686521203 Catalog Number : 052120-000

Device Description : Non-hardening zinc oxide eugenol temporary dental cement

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : EMB

Prescription Use : No

Device Count : 1

Waterpik Neo-Temp Temporary Resin Cement - D6865220030 Catalog Number : 052200-000

Device Description : Resin Cement Kit containing Part A (10g), Part B (10g), Neo-Seal Dentin Sealant Resin Cement Kit containing Part A (10g), Part B (10g), Neo-Seal Dentin Sealant (15ml), Releasing Agent (1.5g)

Device Class : 2

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : EMA

Prescription Use : No

Device Count : 1

Waterpik Wizard Wedges - D686613083 Catalog Number : 061308-000

Device Description : Anatomical wood matrix wedges, large (purple)

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 400

Waterpik Wizard Wedges - D686613093 Catalog Number : 061309-000

Device Description : Anatomical wood matrix wedges, extra large (red)

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 400

Waterpik Wizard Wedges - D686613103 Catalog Number : 061310-000

Device Description : Anatomical wood matrix wedges, assortment of sizes - 100 ea - small, medium, lar Anatomical wood matrix wedges, assortment of sizes - 100 ea - small, medium, large, and extra large

Device Class : 1

Duns Number: 001804074

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 400

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