# K182625: Diapex Plus

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Jun 3, 2019 after 252 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 K973667 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973667: Vitapex Pre-Loaded Dental Syringe, Neodental Chemical Products Co., Ltd. (1997) Summary page 4.
- K032603: Metapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling, Meta Biomed Co., Ltd. (2003) Summary page 4.

## Most influential descendants
- K202617: Metapex Plus (2021), 0 descendants of its own

## Indications for use
DIAPEX 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/K182625
Methodology: https://510kreport.com/methodology