Flexcera™ Smile Ultra+ B1 RES-01-3150

GUDID 04260683220447

Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.

Envisiontec GmbH

Temporary dental crown/bridge resin

• Primary Device ID: 04260683220447
• NIH Device Record Key: f6e22239-80d8-4be5-8191-1aa94814ac05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexcera™ Smile Ultra+ B1
• Version Model Number: RES-01-3150
• Catalog Number: RES-01-3150
• Company DUNS: 332025159
• Company Name: Envisiontec GmbH
• 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: false
• Device Combination Product: false
• Single Use: false
• 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: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de
• Phone: +49204398750
• Email: info@envisiontec.de

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260683220447 [Primary]

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2022-01-31
• Device Publish Date: 2022-01-21

Devices Manufactured by Envisiontec GmbH

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• 04260683220928 - Flexcera™ Base Ultra+ Medium Pink: 2023-09-21 Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial dent
• 04260683220935 - Flexcera™ Base Ultra+ Dark Pink: 2023-09-21 Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial dent
• 04260683220942 - Flexcera Base Ultra+ Light Pink: 2023-09-21 Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial dent
• 04260683220959 - Flexcera Base Ultra+ Dark Meharry: 2023-09-21 Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial dent
• 04260683220836 - Flexcera™ Smile Ultra+ for Carbon® Printers Bleach: 2023-08-10 Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and
• 04260683220843 - Flexcera™ Smile Ultra+ for Carbon® Printers A1: 2023-08-10 Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and
• 04260683220850 - Flexcera™ Smile Ultra+ for Carbon® Printers A2: 2023-08-10 Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and