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 Number: 3012389497
• FEI Number: 3012389497
• Name: Jennifer Hadfield
• Owner & Operator: EnvisionTEC GmbH
• Contact Address: Bruesseler Strasse 51 ; Gladbeck DE-NW Nordrhein-Westfalen D-45968 DE
• Official Correspondent:
  • Jennifer Hadfield
  • 49-204-398750-x
• US Agent:
  • Jennifer Hadfield
  • Qserve Group US, Inc.
  • 603 3693550
  • jennifer.hadfield@qservegroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1 Boston Pl Ste 2600 ; Boston, MA 02108 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3009261582
• FEI Number: 3009261582
• Name: EnvisionTEC Inc.
• Owner & Operator: EnvisionTEC GmbH
• Contact Address: Bruesseler Strasse 51 ; Gladbeck DE-NW Nordrhein-Westfalen D-45968 DE
• Official Correspondent:
  • Jennifer Hadfield
  • 49-204-398750-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 15162 S Commerce Dr ; Dearborn, MI 48120 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04260683220959 Envisiontec GmbH	Flexcera Base Ultra+ Dark Meharry RES-01-3504	2023-09-21
GUDID 04260683220942 Envisiontec GmbH	Flexcera Base Ultra+ Light Pink RES-01-3503	2023-09-21
GUDID 04260683220935 Envisiontec GmbH	Flexcera™ Base Ultra+ Dark Pink RES-01-3502	2023-09-21
GUDID 04260683220928 Envisiontec GmbH	Flexcera™ Base Ultra+ Medium Pink RES-01-3501	2023-09-21
GUDID 04260683220911 Envisiontec GmbH	Flexcera Base Ultra+ Pink RES-01-3500	2023-09-21
GUDID 04260683220867 Envisiontec GmbH	Flexcera™ Smile Ultra+ for Carbon® Printers B1 RES-01-3350	2023-08-10
GUDID 04260683220850 Envisiontec GmbH	Flexcera™ Smile Ultra+ for Carbon® Printers A2 RES-01-3347	2023-08-10
GUDID 04260683220843 Envisiontec GmbH	Flexcera™ Smile Ultra+ for Carbon® Printers A1 RES-01-3346	2023-08-10
GUDID 04260683220836 Envisiontec GmbH	Flexcera™ Smile Ultra+ for Carbon® Printers Bleach RES-01-3351	2023-08-10
GUDID 04260683220652 Envisiontec GmbH	SmileGuard RES-01-3194	2022-08-29
PMN K220894 EnvisionTEC GmbH	SmileGuard	2022-06-10
GUDID 04260683220515 Envisiontec GmbH	Flexcera™ Smile Ultra+ Bleach 0.5kg RES-01-3187	2022-01-31
GUDID 04260683220508 Envisiontec GmbH	Flexcera™ Smile Ultra+ B1 0.5kg RES-01-3186	2022-01-31
GUDID 04260683220492 Envisiontec GmbH	Flexcera™ Smile Ultra+ A3.5 0.5kg RES-01-3185	2022-01-31
GUDID 04260683220485 Envisiontec GmbH	Flexcera™ Smile Ultra+ A3 0.5kg RES-01-3184	2022-01-31
GUDID 04260683220478 Envisiontec GmbH	Flexcera™ Smile Ultra+ A2 0.5kg RES-01-3183	2022-01-31
GUDID 04260683220461 Envisiontec GmbH	Flexcera™ Smile Ultra+ A1 0.5kg RES-01-3182	2022-01-31
GUDID 04260683220454 Envisiontec GmbH	Flexcera™ Smile Ultra+ Bleach RES-01-3151	2022-01-31
GUDID 04260683220447 Envisiontec GmbH	Flexcera™ Smile Ultra+ B1 RES-01-3150	2022-01-31
GUDID 04260683220430 Envisiontec GmbH	Flexcera™ Smile Ultra+ A3.5 RES-01-3149	2022-01-31
GUDID 04260683220423 Envisiontec GmbH	Flexcera™ Smile Ultra+ A3 RES-01-3148	2022-01-31
GUDID 04260683220416 Envisiontec GmbH	Flexcera™ Smile Ultra+ A2 RES-01-3147	2022-01-31
GUDID 04260683220409 Envisiontec GmbH	Flexcera™ Smile Ultra+ A1 RES-01-3146	2022-01-31
PMN K210977 EnvisionTEC GmbH	E-Dent 1000	2021-05-25
GUDID 04260683220386 Envisiontec GmbH	Flexcera Base Dark Meharry RES-01-3144	2021-05-14
GUDID 04260683220379 Envisiontec GmbH	Flexcera Base Light Pink RES-01-3143	2021-05-14
GUDID 04260683220362 Envisiontec GmbH	Flexcera Base Dark Pink RES-01-3142	2021-05-14
GUDID 04260683220355 Envisiontec GmbH	Flexcera Base Medium Pink RES-01-3141	2021-05-14
GUDID 04260683220348 Envisiontec GmbH	Flexcera Base Original Pink RES-01-3140	2021-05-14
GUDID 04260683220331 Envisiontec GmbH	Flexcera Smile Bleach RES-01-3139	2021-04-27
GUDID 04260683220324 Envisiontec GmbH	Flexcera Smile B1 RES-01-3138	2021-04-27
GUDID 04260683220317 Envisiontec GmbH	Flexcera Smile A3.5 RES-01-3137	2021-04-27
GUDID 04260683220300 Envisiontec GmbH	Flexcera Smile A3 RES-01-3136	2021-04-27
GUDID 04260683220294 Envisiontec GmbH	Flexcera Smile A2 RES-01-3135	2021-04-27
GUDID 04260683220287 Envisiontec GmbH	Flexcera Smile A1 RES-01-3134	2021-04-27
PMN K203641 EnvisionTEC GmbH	E-Denture Pro	2021-03-30
GUDID 04260683220041 Envisiontec GmbH	E-Guard Blue RES-01-3121	2020-12-25
GUDID 04260683220102 Envisiontec GmbH	E-Guard RES-01-3113	2020-12-10
PMN K201173 EnvisionTEC GmbH	E-Guard	2020-11-27
GUDID 04260683220171 Envisiontec GmbH	E-Tray RES-01-3114	2020-10-15
GUDID 04260683220140 Envisiontec GmbH	E-Guide Soft RES-01-3115	2020-10-15
GUDID 04260683220133 Envisiontec GmbH	E-Guide RES-01-3012	2020-09-10
GUDID 42606832201330 Envisiontec GmbH	E-Guide RES-01-3012	2020-08-19
KXG Jennifer Hadfield [EnvisionTEC GmbH]	NP Swabs	2020-04-03
KXG Jennifer Hadfield [EnvisionTEC GmbH]	E1-Guide Soft C-29C	2020-04-03
KXG EnvisionTEC Inc. [EnvisionTEC GmbH]	NP Swabs	2020-04-03
KXG EnvisionTEC Inc. [EnvisionTEC GmbH]	E1-Guide Soft C-29C	2020-04-03
KXF Jennifer Hadfield [EnvisionTEC GmbH]	NP Swabs	2020-04-03
KXF EnvisionTEC Inc. [EnvisionTEC GmbH]	NP Swabs	2020-04-03
NDP Jennifer Hadfield [EnvisionTEC GmbH]	E-Guide	2016-12-19