ARGILITE 4 GOLD ALLOY FOR PORCELAIN— 510(k) K903686

Substantially Equivalent

Argen Precious Metals, Inc.

FDA 510(k) clearance K903686 for ARGILITE 4 GOLD ALLOY FOR PORCELAIN, Substantially Equivalent on 1990-08-29. Applicant: Argen Precious Metals, Inc..

Clearance details

Applicant: Argen Precious Metals, Inc.
Product code: Code EFT
Advisory panel: Dental
Date received: 1990-08-13
Decision date: 1990-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

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.