E-Guard RES-01-3113

GUDID 04260683220102

E-Guard is a light-curing material for the additive manufacturing of individual dental bite splints.

Envisiontec GmbH

Dental occlusal splint, custom-made

• Primary Device ID: 04260683220102
• NIH Device Record Key: f21b4604-b699-4fb1-90fd-49ce9f1bbcaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Guard
• Version Model Number: RES-01-3113
• Catalog Number: RES-01-3113
• Company DUNS: 332025159
• Company Name: Envisiontec GmbH
• 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: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com
• Phone: +49204398750
• Email: info@envisiontec.com

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
• 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	04260683220102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201173

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2020-12-10
• Device Publish Date: 2020-12-02

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• 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
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• 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