MEISINGER TUNGSTEN CARBIDE & STEEL DT.B.— 510(k) K802989

Name: FDA 510(k) clearance K802989
Creator: U.S. Food and Drug Administration
Published: 1980-12-30

Substantially Equivalent

Swiss American Metal Craft Corp.

FDA 510(k) clearance K802989 for MEISINGER TUNGSTEN CARBIDE & STEEL DT.B., Substantially Equivalent on 1980-12-30. Applicant: Swiss American Metal Craft Corp.. Device class: 1.

Clearance details

Applicant: Swiss American Metal Craft Corp.
Product code: Code EJL
Device class: Class 1
Regulation: 21 CFR 872.3240
Advisory panel: Dental
Date received: 1980-11-21
Decision date: 1980-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Swiss American Metal Craft Corp.

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K802984 — MEISINGER DIAMOND DENTAL BURS1980-12-30
K802987 — JOTA DIAMOND DENTAL BURS1980-12-30
K802988 — JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS1980-12-30

Adverse events under product code EJL

product code EJL

Other: 1
Total: 1

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.