EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400— 510(k) K112869
Substantially EquivalentBeyes Dental Canada, Inc.
FDA 510(k) clearance K112869 for EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400, Substantially Equivalent on 2011-12-16. Applicant: Beyes Dental Canada, Inc.. Device class: 1.
Clearance details
- Applicant
- Beyes Dental Canada, Inc.
- Product code
- Code EFB
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dover, DE, US
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More clearances from Beyes Dental Canada, Inc.
view allAdverse 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.