MICRO-DISPENSER 7000 & MICRODISPENSER 8000— 510(k) K954722

Substantially Equivalent

NOUVAG AG

FDA 510(k) clearance K954722 for MICRO-DISPENSER 7000 & MICRODISPENSER 8000, Substantially Equivalent on 1996-01-16. Applicant: NOUVAG AG.

Clearance details

Applicant: NOUVAG AG
Product code: Code EFB
Advisory panel: Dental
Date received: 1995-10-13
Decision date: 1996-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.