MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT— 510(k) K914041
Substantially EquivalentMidwest Implant Sales, Inc.
FDA 510(k) clearance K914041 for MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT, Substantially Equivalent on 1991-12-09. Applicant: Midwest Implant Sales, Inc.. Device class: 2.
Clearance details
- Applicant
- Midwest Implant Sales, Inc.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schaumburg, IL, US
Recent devices under product code DZE
view allMore clearances from Midwest Implant Sales, Inc.
view allAdverse 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.