PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS— 510(k) K130076
Substantially EquivalentMerz Dental GmbH
FDA 510(k) clearance K130076 for PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS, Substantially Equivalent on 2013-08-22. Applicant: Merz Dental GmbH.
Clearance details
- Applicant
- Merz Dental GmbH
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Albuquerque, NM, US
Adverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
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.