SilentZPro 2.0— 510(k) K220688
Substantially EquivalentShinrin-Yoku Traders, LLC
FDA 510(k) clearance K220688 for SilentZPro 2.0, Substantially Equivalent on 2022-12-02. Applicant: Shinrin-Yoku Traders, LLC.
Clearance details
- Applicant
- Shinrin-Yoku Traders, LLC
- Product code
- Code LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sherwood, OR, US
Adverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
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.