Improv Temporary Implant Cement by Dentegris Dental Implant System AV-4400

GUDID D801AV44001

Improv - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants and Conventional Crown and Bridge Restorations.

SCIENTIFIC PHARMACEUTICALS, INC.

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• Primary Device ID: D801AV44001
• NIH Device Record Key: c83af62e-0b81-44ab-878d-051e79f6557c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Improv Temporary Implant Cement by Dentegris Dental Implant System
• Version Model Number: AV-4400
• Catalog Number: AV-4400
• Company DUNS: 096010525
• Company Name: SCIENTIFIC PHARMACEUTICALS, 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: true
• 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: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de
• Phone: +492841882710
• Email: matthias.matthes@dentegris.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801AV44001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982400

FDA Product Code

• EMA: Cement, Dental

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: 2020-12-21
• Device Publish Date: 2020-12-11

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