K032995

Substantially Equivalent

SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)

Applicant: Micron Corp.
Product code: ELC
Advisory panel: Dental
Date received: 2003-09-25
Decision date: 2003-11-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Ota-Ku, Tokyo, JP

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.