SmileGuard RES-01-3194

GUDID 04260683220652

SmileGuard is a light-curing material for the additive manufacuring of flexible, individual dental bite splints.

Envisiontec GmbH

Dental occlusal splint, custom-made

• Primary Device ID: 04260683220652
• NIH Device Record Key: e7ebdb59-dbb3-4ec1-b87a-838717d94839
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmileGuard
• Version Model Number: RES-01-3194
• Catalog Number: RES-01-3194
• 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: 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
• 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

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260683220652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220894

FDA Product Code

• KMY: Positioner, Tooth, Preformed

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: 2022-08-29
• Device Publish Date: 2022-08-19

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