OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW— 510(k) K952634

Substantially Equivalent

Opti-Max

FDA 510(k) clearance K952634 for OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW, Substantially Equivalent on 1995-09-18. Applicant: Opti-Max.

Clearance details

Applicant: Opti-Max
Product code: Code DZE
Advisory panel: Dental
Date received: 1995-06-08
Decision date: 1995-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Ludlow, WA, 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.