E-Tray RES-01-3114

GUDID 04260683220171

E-Tray is a light-curing material for the additive manufacturing of individual dental impression trays and bite template bases

Envisiontec GmbH

Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material

• Primary Device ID: 04260683220171
• NIH Device Record Key: df93d4f4-90e6-4762-87ba-f57089f9f79e
• Commercial Distribution Discontinuation: 2020-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: E-Tray
• Version Model Number: RES-01-3114
• Catalog Number: RES-01-3114
• 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: 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260683220171 [Primary]

FDA Product Code

• EBH: Material, Impression Tray, 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: 2020-10-15
• Device Publish Date: 2020-10-07

Devices Manufactured by Envisiontec GmbH

• 04260683220911 - Flexcera Base Ultra+ Pink: 2023-09-21 Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial dent
• 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