THE WOOG ORABRUSH— 510(k) K871406

Substantially Equivalent

Woog Intl.

FDA 510(k) clearance K871406 for THE WOOG ORABRUSH, Substantially Equivalent on 1987-07-07. Applicant: Woog Intl.. Device class: 1.

Clearance details

Applicant
Woog Intl.
Product code
Code JEQ
Device class
Class 1
Regulation
21 CFR 872.6865
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Philadelphia, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JEQ

product code JEQ
Injury
188
Malfunction
2,818
Total
3,006

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.