Waterpik Key-To Alginate Impression Material 013111-000

GUDID D6860131119

Regular Body, Regular Set

WATER PIK, INC.

Alginate dental impression material

• Primary Device ID: D6860131119
• NIH Device Record Key: 32c13680-bd80-4b60-a146-0e9e35b427f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waterpik Key-To Alginate Impression Material
• Version Model Number: 013111-000
• Catalog Number: 013111-000
• 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: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6860131119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970594

FDA Product Code

• ELW: Material, Impression

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: 2023-06-26
• Device Publish Date: 2016-08-02

On-Brand Devices [Waterpik Key-To Alginate Impression Material]

• D68601312612: Alginate Impression Material, Heavy Body - Fast Set, 25lb (11.34kg) drum
• D68601311396: Alginate Impression Material, Regular Body - Fast Set, 1lb (454g) can
• D68601311295: Alginate Impression Material, Heavy Body - Fast Set, 1lb (454g) can
• D68601311194: Alginate Impression Material, Regular Body - Regular Set, 1lb (454g) can
• D6860131261: Heavy Body, Fast Set
• D6860131139: Regular Body, Fast Set
• D6860131129: Heavy Body, Fast Set
• D6860131119: Regular Body, Regular Set