SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B3— 510(k) K953234
Substantially EquivalentThe Implant Center of the Palm Beaches
FDA 510(k) clearance K953234 for SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B3, Substantially Equivalent on 1995-11-08. Applicant: The Implant Center of the Palm Beaches.
Clearance details
- Applicant
- The Implant Center of the Palm Beaches
- Product code
- Code DZE
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- N. Palm Beach, FL, 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.