Custom Legacy and Custom InterActive Titanium Abutments— 510(k) K192218
Substantially EquivalentImplant Direct Sybron Manufacturing, LLC
FDA 510(k) clearance K192218 for Custom Legacy and Custom InterActive Titanium Abutments, Substantially Equivalent on 2020-05-08. Applicant: Implant Direct Sybron Manufacturing, LLC.
Clearance details
- Applicant
- Implant Direct Sybron Manufacturing, LLC
- Product code
- Code NHA
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Thousand Oaks, CA, US
Adverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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.