ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP— 510(k) K932990

Substantially Equivalent

Oral-B Laboratories

FDA 510(k) clearance K932990 for ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP, Substantially Equivalent on 1993-09-29. Applicant: Oral-B Laboratories.

Clearance details

Applicant
Oral-B Laboratories
Product code
Code EFB
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Redwood City, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EFB

product code EFB
Injury
133
Malfunction
562
Total
695

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.