ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM— 510(k) K102981

Substantially Equivalent

Ace Surgical Supply Company, Inc.

FDA 510(k) clearance K102981 for ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2010-12-20. Applicant: Ace Surgical Supply Company, Inc..

Clearance details

Applicant: Ace Surgical Supply Company, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2010-10-07
Decision date: 2010-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Brockton, 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.