# K032662: Guttaflow

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent GmbH & Co. KG
- Decided: Nov 3, 2003 after 67 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 K973539 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973539: Roeko Calcium Hydroxide Points, Roeko USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K190510: GuttaSil (2019), 0 descendants of its own

## Indications for use
GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.

Source page: https://510kreport.com/device/K032662
Methodology: https://510kreport.com/methodology