# K202617: Metapex Plus

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Apr 14, 2021 after 217 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: 3 generations back to K973667 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182625: Diapex Plus, DiaDent Group International (2019)

## Indications for use
Metapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material. * Application: Root canal filling material/Apexification and hard tissue formation/Apexogensis

Source page: https://510kreport.com/device/K202617
Methodology: https://510kreport.com/methodology