Acu-Flow™ Monophase 1-016404

GUDID 07540172018876

Hydrophillic Impression Material

CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Silicone dental impression material

• Primary Device ID: 07540172018876
• NIH Device Record Key: a25e363e-e59f-4e8f-baa1-40b05507fcff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acu-Flow™ Monophase
• Version Model Number: 1-016404
• Catalog Number: 1-016404
• Company DUNS: 626406016
• Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com

Device Dimensions

• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter
• Device Size Text, specify: 0
• Total Volume: 300 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Storage Environment Temperature: Between 17 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540172018876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053018

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-04
• Device Publish Date: 2021-07-27