BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)— 510(k) K964330

Substantially Equivalent

BioHorizons Implant Systems, Inc.

FDA 510(k) clearance K964330 for BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE), Substantially Equivalent on 1997-01-17. Applicant: BioHorizons Implant Systems, Inc..

Clearance details

Applicant: BioHorizons Implant Systems, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 1996-10-31
Decision date: 1997-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, AL, 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.