# Envisiontec GmbH

- Location (FDA's records): Gladbeck, DE
- FDA decisions: 5 (2020–2022): 5 510(k) clearances
- Product codes: MQC (2), EBG (1), EBF (1), EBI (1)
- 510(k) review time since 2016: median 74 days, against 178 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Deltamed GmbH: 1 (https://510kreport.com/company/deltamed)
- Keystone Industries: 1 (https://510kreport.com/company/keystone-industries)
- Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG: 1 (https://510kreport.com/company/bego-bremer-goldschlagerei-wilh-herbst)
- Wieland Dental + Technik GmbH & Co. KG: 1 (https://510kreport.com/company/wieland-dental-technik)
- Vertex-Dental B.V.: 1 (https://510kreport.com/company/vertex-dental)
- Whip-Mix Corp.: 1 (https://510kreport.com/company/whip-mix)

## Firms that cite its devices most
- Sprintray, Inc.: 2 (https://510kreport.com/company/sprintray)
- Asiga Pty, Ltd.: 1 (https://510kreport.com/company/asiga)
- Keystone Industries: 1 (https://510kreport.com/company/keystone-industries)
- Shenzhen Piocreat 3D Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-piocreat-3d-technology)
- Stratasys, Ltd.: 1 (https://510kreport.com/company/stratasys)
- Dmg Digital Enterprises SE: 1 (https://510kreport.com/company/dmg-digital-enterprises)
- Harvest Dental Products, LLC: 1 (https://510kreport.com/company/harvest-dental-products)

## Its most-cited devices
- K210977: E-Dent 1000 (2021), cited by 3
- K211101: E-Temp (2021), cited by 2
- K201173: E-Guard (2020), cited by 2
- K203641: E-Denture Pro (2021), cited by 1

## Recent decisions
- K220894: SmileGuard (Jun 10, 2022)
- K211101: E-Temp (Jun 14, 2021)
- K210977: E-Dent 1000 (May 25, 2021)
- K203641: E-Denture Pro (Mar 30, 2021)
- K201173: E-Guard (Nov 27, 2020)

Source page: https://510kreport.com/company/envisiontec