# K992582: Pacific Implant Titanium Endodontic Point

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Implant, Inc.
- Decided: Oct 21, 1999 after 80 days
- Product code: EKL (Point, Silver, Endodontic)
- Device class: 1
- Regulation: 21 CFR 872.3840
- 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) Silver endodontic points marketed by Pulpdent Corporation: named in the summary without a submission number

## Indications for use
The Pacific Implant Titanium Endodontic Point is intended for use during endodontic therapy to fill permanently the root canal of a tooth.

Source page: https://510kreport.com/device/K992582
Methodology: https://510kreport.com/methodology