Waterpik Barrier Dentin Sealant 042305-000

GUDID D686423053

Cavity varnish, coronal sealant for endodontic procedures, and short-term protectant for exposed root surfaces.

WATER PIK, INC.

Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish

• Primary Device ID: D686423053
• NIH Device Record Key: 4570f0e7-8a1a-47fd-8389-e936fdce4fa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waterpik Barrier Dentin Sealant
• Version Model Number: 042305-000
• Catalog Number: 042305-000
• Company DUNS: 001804074
• Company Name: WATER PIK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com

Device Dimensions

• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D686423053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K852756

FDA Product Code

• LBH: Varnish, Cavity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-06-21
• Device Publish Date: 2016-07-29

On-Brand Devices [Waterpik Barrier Dentin Sealant]

• D6864230535: Cavity varnish, Kit containing 15ml of sealant and 50 pipettes.
• D686423053: Cavity varnish, coronal sealant for endodontic procedures, and short-term protectant for exposed