POSI-STOP/POSI-TRAC SYSTEM— 510(k) K981997
Substantially EquivalentThe Dental Medical Device Co., LLC
FDA 510(k) clearance K981997 for POSI-STOP/POSI-TRAC SYSTEM, Substantially Equivalent on 1999-01-12. Applicant: The Dental Medical Device Co., LLC.
Clearance details
- Applicant
- The Dental Medical Device Co., LLC
- Product code
- Code DZE
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montville, NJ, US
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
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.