Waterpik Getz Blue Core 041418-000

GUDID D686414183

Light-cured crown build-up material

WATER PIK, INC.

Dental prosthesis restorative material, unfilled resin

• Primary Device ID: D686414183
• NIH Device Record Key: 7253643d-59c5-4037-82bd-f6a7f7144d86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waterpik Getz Blue Core
• Version Model Number: 041418-000
• Catalog Number: 041418-000
• 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
• Phone: (800) 525-2020
• Email: professional@waterpik.com
• Phone: (800) 525-2020
• Email: professional@waterpik.com

Device Dimensions

• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D686414183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832781

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-06-13
• Device Publish Date: 2016-07-27

On-Brand Devices [Waterpik Getz Blue Core]

• D6864141839: Crown build-up material, single 5 g syringe
• D686414183: Light-cured crown build-up material