# K971641: Antibacterial Gutta Percha

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Howard Martin, P.A.
- Decided: Jul 21, 1997 after 80 days
- Product code: EKM (Gutta-Percha)
- Device class: 1
- Regulation: 21 CFR 872.3850
- 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
For use in the final filling of prepared-root canals in adult or deciduous teeth when antibacterial activity is desired in the final filling agent. Used to promote healing effects and to help prevent bacterial contamination of the canal. A root canal filler with antibacterial properties indicated in cases where antibacterial properties coupled with excellent physical characteristics for complete filling of the root canal are needed.

Source page: https://510kreport.com/device/K971641
Methodology: https://510kreport.com/methodology