AB DENTAL DEVICES IMPLANTS AND ACCESSORIES— 510(k) K112440
Substantially EquivalentA.B. Dental Devices , Ltd.
FDA 510(k) clearance K112440 for AB DENTAL DEVICES IMPLANTS AND ACCESSORIES, Substantially Equivalent on 2012-04-18. Applicant: A.B. Dental Devices , Ltd..
Clearance details
- Applicant
- A.B. Dental Devices , Ltd.
- Product code
- Code DZE
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ramat Hasharon,, IL
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
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.