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

• 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