Envisiontec G M B H

FDA Filings

This page includes the latest FDA filings for Envisiontec G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012389497
FEI Number3012389497
NameJennifer Hadfield
Owner & OperatorEnvisionTEC GmbH
Contact AddressBruesseler Strasse 51
Gladbeck DE-NW Nordrhein-Westfalen D-45968 DE
Official Correspondent
  • Jennifer Hadfield
  • 49-204-398750-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1 Boston Pl Ste 2600
Boston, MA 02108 US
Establishment TypeManufacture Medical Device



Registration Number3009261582
FEI Number3009261582
NameEnvisionTEC Inc.
Owner & OperatorEnvisionTEC GmbH
Contact AddressBruesseler Strasse 51
Gladbeck DE-NW Nordrhein-Westfalen D-45968 DE
Official Correspondent
  • Jennifer Hadfield
  • 49-204-398750-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address15162 S Commerce Dr
Dearborn, MI 48120 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
EnvisionTEC GmbH
SmileGuard2022-06-10
Envisiontec GmbH
Flexcera™ Smile Ultra+ Bleach 0.5kg RES-01-31872022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ B1 0.5kg RES-01-31862022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ A3.5 0.5kg RES-01-31852022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ A3 0.5kg RES-01-31842022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ A2 0.5kg RES-01-31832022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ A1 0.5kg RES-01-31822022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ Bleach RES-01-31512022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ B1 RES-01-31502022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ A3.5 RES-01-31492022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ A3 RES-01-31482022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ A2 RES-01-31472022-01-31
Envisiontec GmbH
Flexcera™ Smile Ultra+ A1 RES-01-31462022-01-31
Envisiontec GmbH
Flexcera Base Dark Meharry RES-01-31442021-05-14
Envisiontec GmbH
Flexcera Base Light Pink RES-01-31432021-05-14
Envisiontec GmbH
Flexcera Base Dark Pink RES-01-31422021-05-14
Envisiontec GmbH
Flexcera Base Medium Pink RES-01-31412021-05-14
Envisiontec GmbH
Flexcera Base Original Pink RES-01-31402021-05-14
Envisiontec GmbH
Flexcera Smile Bleach RES-01-31392021-04-27
Envisiontec GmbH
Flexcera Smile B1 RES-01-31382021-04-27
Envisiontec GmbH
Flexcera Smile A3.5 RES-01-31372021-04-27
Envisiontec GmbH
Flexcera Smile A3 RES-01-31362021-04-27
Envisiontec GmbH
Flexcera Smile A2 RES-01-31352021-04-27
Envisiontec GmbH
Flexcera Smile A1 RES-01-31342021-04-27
EnvisionTEC GmbH
E-Denture Pro2021-03-30
Envisiontec GmbH
E-Guard Blue RES-01-31212020-12-25
Envisiontec GmbH
E-Guard RES-01-31132020-12-10
EnvisionTEC GmbH
E-Guard2020-11-27
Envisiontec GmbH
E-Tray RES-01-31142020-10-15
Envisiontec GmbH
E-Guide Soft RES-01-31152020-10-15
Envisiontec GmbH
E-Guide RES-01-3012 2020-09-10
Envisiontec GmbH
E-Guide RES-01-3012 2020-08-19
Jennifer Hadfield [EnvisionTEC GmbH]
NP Swabs2020-04-03
Jennifer Hadfield [EnvisionTEC GmbH]
E1-Guide Soft C-29C2020-04-03
EnvisionTEC Inc. [EnvisionTEC GmbH]
NP Swabs2020-04-03
EnvisionTEC Inc. [EnvisionTEC GmbH]
E1-Guide Soft C-29C2020-04-03
Jennifer Hadfield [EnvisionTEC GmbH]
NP Swabs2020-04-03
EnvisionTEC Inc. [EnvisionTEC GmbH]
NP Swabs2020-04-03
Jennifer Hadfield [EnvisionTEC GmbH]
E-Guide2016-12-19

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