# K812116: Permagum

- Pathway: 510(k) (Traditional)
- Applicant: Espe-Premier Sales Co.
- Decided: Aug 31, 1981 after 35 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960547: Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive (1996), 11 descendants of its own
- 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

Source page: https://510kreport.com/device/K812116
Methodology: https://510kreport.com/methodology