THE AUTOTAC SYSTEM— 510(k) K011675

Substantially Equivalent

BioHorizons Implant Systems, Inc.

FDA 510(k) clearance K011675 for THE AUTOTAC SYSTEM, Substantially Equivalent on 2001-06-22. Applicant: BioHorizons Implant Systems, Inc..

Clearance details

Applicant: BioHorizons Implant Systems, Inc.
Product code: Code DZL
Advisory panel: Dental
Date received: 2001-05-30
Decision date: 2001-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Birmingham, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.