DURAFLEX— 510(k) K063626
Substantially EquivalentCosmetic Dental Materials, Inc.
FDA 510(k) clearance K063626 for DURAFLEX, Substantially Equivalent on 2007-02-08. Applicant: Cosmetic Dental Materials, Inc..
Clearance details
- Applicant
- Cosmetic Dental Materials, Inc.
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Albany, OR, 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.