SP4044 & SP4055 LUX MODULES— 510(k) K972026

Substantially Equivalent

Satelec

FDA 510(k) clearance K972026 for SP4044 & SP4055 LUX MODULES, Substantially Equivalent on 1997-07-09. Applicant: Satelec.

Clearance details

Applicant: Satelec
Product code: Code ELC
Advisory panel: Dental
Date received: 1997-06-02
Decision date: 1997-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.