MONOJECT ROOT CANAL FILLING MAT. NEEDLE— 510(k) K802811

Substantially Equivalent

Sherwood Medical Co.

FDA 510(k) clearance K802811 for MONOJECT ROOT CANAL FILLING MAT. NEEDLE, Substantially Equivalent on 1980-11-24. Applicant: Sherwood Medical Co.. Device class: 1.

Clearance details

Applicant
Sherwood Medical Co.
Product code
Code DZM
Device class
Class 1
Regulation
21 CFR 872.4730
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DZM

product code DZM
Injury
139
Total
139

Source: openFDA MAUDE database, through . 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.