PowerMix™ Automatic Impression Material Dispenser 031121

GUDID 00359883000608

Two-component dental material applicator, electric

DEN-MAT HOLDINGS, LLC

Dental material cartridge-plunging applicator, two-component, electric

• Primary Device ID: 00359883000608
• NIH Device Record Key: f09543de-6758-44da-b1ed-45c92644f69f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerMix™ Automatic Impression Material Dispenser
• Version Model Number: 031121
• Catalog Number: 031121
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com

Device Dimensions

• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram
• Weight: 765 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00359883000608 [Primary]

FDA Product Code

• EFD: AMALGAMATOR, DENTAL, AC-POWERED

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: 2025-03-20
• Device Publish Date: 2025-03-12

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