# K213244: Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)

- Pathway: 510(k) (Traditional)
- Applicant: Prevest Denpro Limited
- Decided: Sep 9, 2022 after 344 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943574 (1994). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171562: Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono, Dreve Dentamid GmbH (2018) Summary page 5.

## Most influential descendants
- K251724: Remi Impression Material (2026), 1 descendant of its own
- K261888: ClearClub Impression Material (2026), 0 descendants of its own
- K251926: enCore Impression Material (2026), 0 descendants of its own

## Indications for use
Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Source page: https://510kreport.com/device/K213244
Methodology: https://510kreport.com/methodology