# K211799: Biodentine XP 500, Biodentine XP 200

- Pathway: 510(k) (Traditional)
- Applicant: Septodont
- Decided: Aug 10, 2021 after 61 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: 1 generation back to K140132 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140132: Biodentine, Septodont (2014) Summary page 4.

## Indications for use
In the crown: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Permanent dentine restoration under composites or Inlay/Onlay - Temporary dentine-enamel restoration; - Restoration of deep and/or large coronal carious lesions (sandwich technique); - Restoration of cervical or radicular lesions. On the pulp: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Pulp capping (direct and indirect). - Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes. In the root: For permanent teeth (immature or mature): - Repair of root perforations; - Repair of furcation perforations; - Repair of perforating internal resorptions; - Repair of external resorption; - Root-end filling in endodontic surgery (retrograde filling). For immature permanent teeth - Apexification

Source page: https://510kreport.com/device/K211799
Methodology: https://510kreport.com/methodology