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