# K011748: First Fill R.C.S.

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Aug 3, 2001 after 58 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- 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 K992097 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992097: Endorez, Ultradent Products, Inc. (1999) Summary page 1.

## Most influential descendants
- K060889: SE Epiphany Root Canal Sealant, Model N59SE (2006), 0 descendants of its own
- K052800: Provisional Inlay/Onlay Kit (2006), 0 descendants of its own

## Indications for use
FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points.

Source page: https://510kreport.com/device/K011748
Methodology: https://510kreport.com/methodology