MACROPORE PROTECTIVE SHEET— 510(k) K983360

Substantially Equivalent

Pacific Materials and Interfaces

FDA 510(k) clearance K983360 for MACROPORE PROTECTIVE SHEET, Substantially Equivalent on 1999-03-19. Applicant: Pacific Materials and Interfaces.

Clearance details

Applicant: Pacific Materials and Interfaces
Product code: Code JEY
Advisory panel: Dental
Date received: 1998-09-24
Decision date: 1999-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.