PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)— 510(k) K980616
Substantially EquivalentKohler Medizintechnik GmbH & Co. KG
FDA 510(k) clearance K980616 for PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15), Substantially Equivalent on 1998-04-30. Applicant: Kohler Medizintechnik GmbH & Co. KG.
Clearance details
- Applicant
- Kohler Medizintechnik GmbH & Co. KG
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Neuhausen, DE
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.