INTEROSSEOUS NEEDLE— 510(k) K761206

Name: FDA 510(k) clearance K761206
Creator: U.S. Food and Drug Administration
Published: 1976-12-13

Substantially Equivalent

Smith & Nephew, Mpl Division

FDA 510(k) clearance K761206 for INTEROSSEOUS NEEDLE, Substantially Equivalent on 1976-12-13. Applicant: Smith & Nephew, Mpl Division. Device class: 1.

Clearance details

Applicant: Smith & Nephew, Mpl Division
Product code: Code DZM
Device class: Class 1
Regulation: 21 CFR 872.4730
Advisory panel: Dental
Date received: 1976-12-07
Decision date: 1976-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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

More clearances from Smith & Nephew, Mpl Division

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K843314 — MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE1984-09-27
K841280 — SOLOPAK BRAND FILTER NEEDLE W/5 MICRO1984-05-21
K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB1984-04-05
K833304 — HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST1984-03-30
K832126 — MICRO Z DISPOS. SPINAL ANESTH. NEEDLE1983-08-12

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.