E-Tray RES-01-3114

GUDID 04260683220171

E-Tray is a light-curing material for the additive manufacturing of individual dental impression trays and bite template bases

Envisiontec GmbH

Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material
Primary Device ID04260683220171
NIH Device Record Keydf93d4f4-90e6-4762-87ba-f57089f9f79e
Commercial Distribution Discontinuation2020-10-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameE-Tray
Version Model NumberRES-01-3114
Catalog NumberRES-01-3114
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]
GS104260683220171 [Primary]

FDA Product Code

EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin
EBHMaterial, Impression Tray, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-15
Device Publish Date2020-10-07

Devices Manufactured by Envisiontec GmbH

04260683220140 - E-Guide Soft2020-10-15 E-Guide Soft is a light-curing material for the additive manufacturing of nasopharyngeal and oropharyngeal swabs
04260683220171 - E-Tray2020-10-15E-Tray is a light-curing material for the additive manufacturing of individual dental impression trays and bite template bases
04260683220171 - E-Tray2020-10-15 E-Tray is a light-curing material for the additive manufacturing of individual dental impression trays and bite template bases
04260683220133 - E-Guide2020-09-10 E-Guide is a light-curing material for the additive manufacturing of individual dental surgical drill guides
42606832201330 - E-Guide2020-08-19 E-Guide is a light-curing material for the additive manufacturing of individual dental surgical drill guides

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