STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION— 510(k) K991436

Substantially Equivalent

Sterngold

FDA 510(k) clearance K991436 for STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION, Substantially Equivalent on 1999-05-07. Applicant: Sterngold.

Clearance details

Applicant: Sterngold
Product code: Code DZE
Advisory panel: Dental
Date received: 1999-04-26
Decision date: 1999-05-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Attleboro, MA, US

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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.