# K220771: Stratasys TrueDent

- Pathway: 510(k) (Traditional)
- Applicant: Stratasys, Ltd.
- Decided: Jul 7, 2022 after 113 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K042819 (2004). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210977: E-Dent 1000, Envisiontec GmbH (2021) Summary page 4.

## Most influential descendants
- K241673: Denture Base Resin (PN-Denture (Red, White)) (2024), 0 descendants of its own

## Recalls of this device
- Jan 19, 2024 · Class III · Z-2091-2025: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not pr
- Jan 19, 2024 · Class III · Z-2094-2025: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not pr
- Jan 19, 2024 · Class III · Z-2090-2025: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not pr
- Jan 19, 2024 · Class III · Z-2093-2025: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not pr
- Jan 19, 2024 · Class III · Z-2092-2025: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not pr

## Indications for use
Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work.

Source page: https://510kreport.com/device/K220771
Methodology: https://510kreport.com/methodology