TERUMO DENTAL NEEDLES— 510(k) K864970

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K864970 for TERUMO DENTAL NEEDLES, Substantially Equivalent on 1987-03-10. Applicant: Terumo Medical Corp..

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code DZM
Advisory panel: Dental
Date received: 1986-12-22
Decision date: 1987-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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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.