Waterpik Neo-Temp Temporary Cement "A" Syringe 052205-000

GUDID D6860522051

“A” syringe refill

WATER PIK, INC.

Dental composite resin

• Primary Device ID: D6860522051
• NIH Device Record Key: c19a5394-0914-4e91-a1ad-97457896b4a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waterpik Neo-Temp Temporary Cement "A" Syringe
• Version Model Number: 052205-000
• Catalog Number: 052205-000
• 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: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6860522051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884081

FDA Product Code

• EMA: Cement, Dental

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: 2023-06-13
• Device Publish Date: 2016-07-29

Devices Manufactured by WATER PIK, INC.

• 00073950333689 - Waterpik PowerPulse with DualDock: 2024-05-07 Hand held shower head, chrome
• 00073950333726 - Waterpik PowerPulse with DualDock: 2024-05-07 Hand held shower head, brushed nickel
• 00073950333924 - Waterpik RainFall+ with PowerPulse: 2024-05-07 Fix mount drencher shower head, chrome
• 00073950334303 - Waterpik PowerPulse: 2024-05-07 Hand held shower head, matte black
• 00073950333184 - Waterpik PowerPulse: 2024-04-10 Hand held shower head, chrome
• 00073950332996 - Waterpik RainFall+ with PowerPulse: 2024-03-25 Fix mount drencher shower head, chrome
• 00073950333122 - Waterpik PowerPulse: 2024-03-25 Fix mount drencher shower head, matte black
• 00073950330251 - Waterpik Sensonic Toothbrush: 2024-03-14 Sonic toothbrush, white