W-H TOPAIR DENTAL HANDPIECE— 510(k) K912786
Substantially EquivalentSabra-The Dental Products Group
FDA 510(k) clearance K912786 for W-H TOPAIR DENTAL HANDPIECE, Substantially Equivalent on 1991-07-17. Applicant: Sabra-The Dental Products Group.
Clearance details
- Applicant
- Sabra-The Dental Products Group
- Product code
- Code EFB
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skokie, IL, 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.