SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE— 510(k) K851524

Name: FDA 510(k) clearance K851524
Creator: U.S. Food and Drug Administration
Published: 1985-09-23

Substantially Equivalent

Specialites Septodont

FDA 510(k) clearance K851524 for SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE, Substantially Equivalent on 1985-09-23. Applicant: Specialites Septodont. Device class: 1.

Clearance details

Applicant: Specialites Septodont
Product code: Code DZM
Device class: Class 1
Regulation: 21 CFR 872.4730
Advisory panel: Dental
Date received: 1985-04-16
Decision date: 1985-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K913573 — SAFETY PLUS DENTAL INJECTION NEEDLE1991-11-07
K910475 — DENTAL NEEDLE PROTECTIVE SYSTEM1991-09-13

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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.