EXEL DENTAL NEEDLE— 510(k) K861150

Name: FDA 510(k) clearance K861150
Creator: U.S. Food and Drug Administration
Published: 1986-04-11

Substantially Equivalent

Exel Intl.

FDA 510(k) clearance K861150 for EXEL DENTAL NEEDLE, Substantially Equivalent on 1986-04-11. Applicant: Exel Intl.. Device class: 1.

Clearance details

Applicant: Exel Intl.
Product code: Code DZM
Device class: Class 1
Regulation: 21 CFR 872.4730
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 ↗

Recent devices under product code DZM

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K990511 — X-TIP INTRAOSSEOUS PERFORATOR1999-04-27
K920758 — JENKER NEEDLE STICK PROTECTOR1992-04-28
K914562 — ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM1992-03-09
K913573 — SAFETY PLUS DENTAL INJECTION NEEDLE1991-11-07
K910475 — DENTAL NEEDLE PROTECTIVE SYSTEM1991-09-13

More clearances from Exel Intl.

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K992290 — EXEL INJECTION PLUG WITH CAP2000-02-23
K963658 — EXEL AVF SINGLE NEEDLE1998-05-05
K963659 — EXEL I.V. ADMINISTRATION SET1997-12-16
K926119 — EXEL HUBER INFUSION SET ROTATING WING1993-08-11
K904685 — EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)1990-11-21

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.