SOLUSET CALCIUM DEMINERALIZING SOLUTION— 510(k) K864976

Name: FDA 510(k) clearance K864976
Creator: U.S. Food and Drug Administration
Published: 1987-02-27

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.. Device class: 1.

Clearance details

Applicant: Endo Technic Corp.
Product code: Code EKS
Device class: Class 1
Regulation: 21 CFR 872.4565
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 ↗

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K970649 — HERO 6421997-05-16
K962031 — QUANTEC SERIES 2000 ENDODONTIC FILES1996-06-04

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K925079 — LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)1994-08-24
K930756 — LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE1994-03-09
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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.