# K092251: Biodentine

- Pathway: 510(k) (Traditional)
- Applicant: Septodont
- Decided: Oct 30, 2009 after 94 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
When used in the crown: Temporary enamel restorative material. Permanent dentine restorative material. Restoration of deep and/or large coronal carious lesions (sandwich technique). Restoration of deep cervical and/or radicular lesions. Pulp capping. Pulpotomy. When used in the root: Repair of root perforations. Repair of furcation perforations. Repair of perforating internal resorptions. Repair of external resorption Apexification. Root-end filling in endodontic surgery (retrograde filling). Biodentine is not to be used for permanent obturation or sealing of the root canal

Source page: https://510kreport.com/device/K092251
Methodology: https://510kreport.com/methodology