PARAGON IMPLANT SYSTEM— 510(k) K953101

Substantially Equivalent

Core-Vent Bio-Engineering, Inc.

FDA 510(k) clearance K953101 for PARAGON IMPLANT SYSTEM, Substantially Equivalent on 1995-12-21. Applicant: Core-Vent Bio-Engineering, Inc..

Clearance details

Applicant: Core-Vent Bio-Engineering, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 1995-07-03
Decision date: 1995-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calabasas, CA, US

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.