# K190503: CeraSeal

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Jun 7, 2019 after 98 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: 7 generations back to K990131 (1999). 29 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080917: Iroot SP, Innovative Bioceramix, Inc. (2008) Summary page 4.

## Most influential descendants
- K262050: Vioseal X (2026), 0 descendants of its own
- K252890: ZenSeal Pro (2026), 0 descendants of its own

## Indications for use
Permanent obturation of the root canal following vital pulp-extirpation Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings CeraSeal is suitable for use in the single cone and lateral condensation technique.

Source page: https://510kreport.com/device/K190503
Methodology: https://510kreport.com/methodology