DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER— 510(k) K033044
Substantially EquivalentAmerican Green Dent. Mfg, Inc.
FDA 510(k) clearance K033044 for DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER, Substantially Equivalent on 2004-12-21. Applicant: American Green Dent. Mfg, Inc..
Clearance details
- Applicant
- American Green Dent. Mfg, Inc.
- Product code
- Code ELC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Adverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
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.