# K971622: Max-I-Probe Endodontic Sealer Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Mpl Technologies, Inc.
- Decided: Jun 20, 1997 after 49 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. The FDA summary names its predicate without a number.
- (no number) Roth International Ltd. Root Canal Cement, Type 801 Elite Grade/Eugenol USP: named in the summary without a submission number

## Indications for use
This device is intended to be used in endodontic therapy as an improved method for applying Zinc Oxide-Eugenol sealing cement directly to the inside surface of a prepared root canal to coat and seal the canal walls prior to the introduction of gutta percha (or other restorative and filling materials).

Source page: https://510kreport.com/device/K971622
Methodology: https://510kreport.com/methodology