HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400— 510(k) K992609
Substantially EquivalentKay See Dental Mfg. Co.
FDA 510(k) clearance K992609 for HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400, Substantially Equivalent on 1999-09-22. Applicant: Kay See Dental Mfg. Co..
Clearance details
- Applicant
- Kay See Dental Mfg. Co.
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kansas City, MO, 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.