Straumann PURE Ceramic Implants— 510(k) K171769
Substantially EquivalentStraumann USA, LLC (On Behalf of Institut Straumann Ag)
FDA 510(k) clearance K171769 for Straumann PURE Ceramic Implants, Substantially Equivalent on 2017-11-14. Applicant: Straumann USA, LLC (On Behalf of Institut Straumann Ag). Device class: 2.
Clearance details
- Applicant
- Straumann USA, LLC (On Behalf of Institut Straumann Ag)
- 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
- Andover, MA, US
Recent devices under product code DZE
view allMore clearances from Straumann USA, LLC (On Behalf of Institut Straumann Ag)
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.