# K201173: E-Guard

- Pathway: 510(k) (Traditional)
- Applicant: Envisiontec GmbH
- Decided: Nov 27, 2020 after 210 days
- Product code: MQC (Mouthguard, Prescription)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924830 (1994). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190107: VeriSplint, Whip Mix Corporation (2019) Summary page 4.

## Most influential descendants
- K222489: Harvest Printable Resin (2023), 0 descendants of its own
- K210940: LuxaPrint Ortho Plus (2021), 0 descendants of its own

## Recalls of this device
- Jan 20, 2022 · Class II · Z-0746-2022: The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

## Indications for use
EnvisionTEC's E-Guard is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations, i.e. bite guards/splints and occlusal night guard/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.

Source page: https://510kreport.com/device/K201173
Methodology: https://510kreport.com/methodology