# K103346: Delikit Putty, Delikit Heavy Body, Delikit Light Body

- Pathway: 510(k) (Traditional)
- Applicant: Sherpa Korea
- Decided: Feb 11, 2011 after 88 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152518: Vonflex S Putty (2015), 4 descendants of its own
- K201483: Impression Material (2020), 2 descendants of its own
- K211489: Dental Impression Material (2021), 1 descendant of its own
- K222741: DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty Set (Regular, Fast) (2022), 0 descendants of its own
- K221668: Dental Impression Material (2022), 0 descendants of its own

## Indications for use
Delikit is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Source page: https://510kreport.com/device/K103346
Methodology: https://510kreport.com/methodology