Flexcera™ Base Ultra+ Dark Pink RES-01-3502
GUDID 04260683220935
Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
Envisiontec GmbH
Denture base resin kit| Primary Device ID | 04260683220935 |
| NIH Device Record Key | 08dd0b85-3d5a-4f09-8b0e-42d9a3a88ef4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flexcera™ Base Ultra+ Dark Pink |
| Version Model Number | RES-01-3502 |
| Catalog Number | RES-01-3502 |
| 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 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com | |
| Phone | +49204398750 |
| info@envisiontec.com |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260683220935 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210977
FDA Product Code
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
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 | 2023-09-21 |
| Device Publish Date | 2023-09-13 |
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 | 2023-09-21Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases |
| 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 |
Trademark Results [Flexcera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEXCERA 90609839 not registered Live/Pending |
Desktop Metal, Inc. 2021-03-29 |
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