BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS— 510(k) K112875

Substantially Equivalent

Blue Sky Bio, LLC

FDA 510(k) clearance K112875 for BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS, Substantially Equivalent on 2012-01-27. Applicant: Blue Sky Bio, LLC.

Clearance details

Applicant: Blue Sky Bio, LLC
Product code: Code DZE
Advisory panel: Dental
Date received: 2011-09-30
Decision date: 2012-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grayslake, IL, 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.