Flexcera Smile A3.5 RES-01-3137

GUDID 04260683220317

Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.

Envisiontec GmbH

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Primary Device ID04260683220317
NIH Device Record Keyeb4cd29a-4ffe-4343-9996-be6ce12c8b9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexcera Smile A3.5
Version Model NumberRES-01-3137
Catalog NumberRES-01-3137
Company DUNS332025159
Company NameEnvisiontec GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104260683220317 [Primary]

FDA Product Code

ELJTeeth, Artificial, Posterior With Metal Insert
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-27
Device Publish Date2021-04-19

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 Pink2023-09-21 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

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