PROSELECT 3 PERIDONTAL THERAPY SYSTEM— 510(k) K964596
Substantially EquivalentProfessional Dental Mfg., Inc.
FDA 510(k) clearance K964596 for PROSELECT 3 PERIDONTAL THERAPY SYSTEM, Substantially Equivalent on 1997-04-22. Applicant: Professional Dental Mfg., Inc..
Clearance details
- Applicant
- Professional Dental Mfg., Inc.
- Product code
- Code ELC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Batesville, AR, 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.