Prosthetic devices · 21 CFR 872 Subpart D
Endodontic Silver Point
FDA device type “Point, Silver, Endodontic”.
- Companies listing it
- 93 makers
- Brands and models
- 7
- 510(k) clearances
- 30 in five years
- FDA name
- Point, Silver, Endodontic
510(k) clearances per year, 1976–2026
Companies that list EKL
9 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Pulpdent Corporation | United States | Maker | EDTA, 17% SOLUTION · File-Rite · Prep-Rite RC | 107 | 2021 |
| Integra LifeSciences Corporation | United States | Maker | Miltex | 2 | 2014 |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Dentsply Sirona, Inc. | United States | Contract manufacturer | — | 148 | 2026 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | ENDO FILE | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Toscana | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | — | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 21 Oct 1999 | K992582 | PACIFIC IMPLANT TITANIUM ENDODONTIC POINT | Pacific Implant, Inc. |
| 23 Apr 1996 | K961089 | PULPDENT ENDOPREP II | Pulpdent Corporation |
| 14 Sep 1982 | K822568 | EAR PROBES | Kelleher Corp. |
Official records: FDA product classification for EKL · 21 CFR 872.3840.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026