# K200175: DIA-ROOT BIO Sealer

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Jun 25, 2020 after 154 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170950: Well-Root ST, Vericom Co., Ltd. (2017) Summary page 4.

## Indications for use
DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.

Source page: https://510kreport.com/device/K200175
Methodology: https://510kreport.com/methodology