# K992727: The BI-Directional Spiral & Epoxy Root Canal Cement System

- Pathway: 510(k) (Traditional)
- Applicant: Mds
- Decided: Jan 18, 2000 after 158 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 K960548 (1996). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960548: AH Plus Root Canal Sealer, Dentsply Intl. (1996) Summary page 1.
- (no number) AH-26® Root Canal Sealer: named in the summary without a submission number

## Most influential descendants
- K042769: Adseal Root Canal Sealer (2004), 7 descendants of its own
- K100248: DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, S (2010), 2 descendants of its own
- K120048: DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S (2012), 1 descendant of its own
- K230010: ADSEAL Plus (2023), 0 descendants of its own
- K202281: EDS Bioceramic Sealer (Bioseal) (2021), 0 descendants of its own

## Indications for use
The Bi-Directional Spiral & Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.

Source page: https://510kreport.com/device/K992727
Methodology: https://510kreport.com/methodology