# K042769: Adseal Root Canal Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Nov 24, 2004 after 50 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: 2 generations back to K960548 (1996). 2 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992727: The BI-Directional Spiral & Epoxy Root Canal Cement System, Mds (2000) Summary page 2.
- K960548: AH Plus Root Canal Sealer, Dentsply Intl. (1996) Summary page 2.
- (no number) Dentsply All 26 Root Canal Sealer (Pre-Amendment Device): named in the summary without a submission number

## Most influential descendants
- 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
- K132123: TRC-Pex, Radic-Sealer (2014), 0 descendants of its own

## Indications for use
Adseal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic procedures and may be used inconjunction with the auxiliary materials in the root canal (i.e. gutta percha points) Adseal is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K042769
Methodology: https://510kreport.com/methodology