# K012405: Extrude Modified

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Sep 4, 2001 after 36 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 Corporation, Extrude: named in the summary without a submission number

## Most influential descendants
- K071192: Blugoo HD (2007), 0 descendants of its own

## Indications for use
Extrude Modified is a multiviscosity polyvinylsiloxane impression material system suitable for all crown and bridge, edentulous and implant impression techniques.

Source page: https://510kreport.com/device/K012405
Methodology: https://510kreport.com/methodology