# K083062: Root Canal XR

- Pathway: 510(k) (Traditional)
- Applicant: S & C Polymer GmbH
- Decided: Mar 12, 2009 after 149 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
System for cleansing, sealing and filling of root canals consisting of 3 products: Canal Cleaner: Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes for use in the effective cleansing of the root canal during root canal preparation. DC Canal Seal SE: DC Canal Seal SE is a simple to use self-etching dual cure sealer for conditioning of root canals and for sealing of side tubuli. DC Root XR: DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates. All directions and all labels are marked with Caution: Federal Law restricts this device to sale by or on the order of a dentist - For dental use only

Source page: https://510kreport.com/device/K083062
Methodology: https://510kreport.com/methodology