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 ID04260683220935
NIH Device Record Key08dd0b85-3d5a-4f09-8b0e-42d9a3a88ef4
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexcera™ Base Ultra+ Dark Pink
Version Model NumberRES-01-3502
Catalog NumberRES-01-3502
Company DUNS332025159
Company NameEnvisiontec GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS104260683220935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-21
Device Publish Date2023-09-13

Devices Manufactured by Envisiontec GmbH

04260683220911 - Flexcera Base Ultra+ Pink2023-09-21 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 Pink2023-09-21 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 Pink2023-09-21Flexcera 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 Pink2023-09-21 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 Pink2023-09-21 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 Meharry2023-09-21 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 Bleach2023-08-10 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 A12023-08-10 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 A22023-08-10 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
FLEXCERA
90609839 not registered Live/Pending
Desktop Metal, Inc.
2021-03-29

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