# K210977: E-Dent 1000

- Pathway: 510(k) (Traditional)
- Applicant: Envisiontec GmbH
- Decided: May 25, 2021 after 54 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K042819 (2004). 29 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201668: VarseoSmile Crown plus, Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG (2020) Summary page 4.
- K151142: Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid, Wieland Dental + Technik GmbH & Co. KG (2015) Summary page 4.

## Most influential descendants
- K222623: Digital Crown (2022), 4 descendants of its own
- K242277: Crown HT (2024), 1 descendant of its own
- K220771: Stratasys TrueDent (2022), 1 descendant of its own
- K261246: SRGC-06 (2026), 0 descendants of its own
- K260152: Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) (2026), 0 descendants of its own

## Indications for use
E-Dent 1000 is a light-curable resin indicated for the fabrication of: » individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area, » individual and fixed single veneers, » artificial teeth for dental prostheses, which are used for removable permanent full dentures, » individual and removable monolithic full and partial dentures in dental laboratories. The material is an alternative to traditional restorative dental material. E-Dent 1000 is intended exclusively for professional dental work. Fabrication of dental applications with E-Dent 1000 requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer’s data, a digital light processing (DLP) printer, and curing light equipment.

Source page: https://510kreport.com/device/K210977
Methodology: https://510kreport.com/methodology