# K960547: Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH & Co. Kg.
- Decided: Mar 15, 1996 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
Longest line of descent: 1 generation back to K812116 (1981). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K812116: Permagum, Espe-Premier Sales Co. (1981) Summary page 1.
- K881838: Modified Permagum Adhesive, Espe GmbH (Us) (1988) Summary page 1.

## Cited in the summary but kept off the family tree
- K890720: Permagum® Garant Light. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K974231: Position Penta, Position Penta Quick (1998), 8 descendants of its own
- K131404: Flash AR Penta / Flash AR Penta Quick (2013), 2 descendants of its own
- K090718: Bellus Shading Kit (2009), 1 descendant of its own
- K991008: Dimension Bite (1999), 1 descendant of its own
- K133436: Flash AR; Flash AR Quick (2014), 0 descendants of its own

## Indications for use
used to make impressions of inlay, onlay, crown and bridge preparations, and edentulous jaws. Polyvinyl Siloxane Adhesive is intended to assure adhesion of impression material to the impression tray and to avoid deformation during impression taking.

Source page: https://510kreport.com/device/K960547
Methodology: https://510kreport.com/methodology