EXEL DENTAL NEEDLE— 510(k) K861150

Substantially Equivalent

Exel Intl.

FDA 510(k) clearance K861150 for EXEL DENTAL NEEDLE, Substantially Equivalent on 1986-04-11. Applicant: Exel Intl..

Clearance details

Applicant: Exel Intl.
Product code: Code DZM
Advisory panel: Dental
Date received: 1986-03-26
Decision date: 1986-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZM

product code DZM

Injury: 139
Total: 139

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.