SOLUSET CALCIUM DEMINERALIZING SOLUTION— 510(k) K864976

Substantially Equivalent

Endo Technic Corp.

FDA 510(k) clearance K864976 for SOLUSET CALCIUM DEMINERALIZING SOLUTION, Substantially Equivalent on 1987-02-27. Applicant: Endo Technic Corp..

Clearance details

Applicant: Endo Technic Corp.
Product code: Code EKS
Advisory panel: Dental
Date received: 1986-12-19
Decision date: 1987-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EKS

product code EKS

Malfunction: 1,949
Total: 1,949

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.