# K091613: TAKE 1

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corp.
- Decided: Oct 7, 2009 after 126 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; 2 cite 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. The FDA summary names its predicate without a number.
- (no number) Kerr VPS Impression Material: named in the summary without a submission number

## Most influential descendants
- K151150: Elements (2015), 3 descendants of its own
- K223892: DentMix VPS Impression Material (2023), 2 descendants of its own
- K254152: Dia-X Sil Light Body (2026), 0 descendants of its own
- K254142: Dia-X Sil Heavy Body (2026), 0 descendants of its own
- K130869: Take 1 Advance (2013), 0 descendants of its own

## Indications for use
Take I 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/K091613
Methodology: https://510kreport.com/methodology