DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980— 510(k) K063384

Substantially Equivalent

Hoya Conbio, Inc.

FDA 510(k) clearance K063384 for DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980, Substantially Equivalent on 2007-03-16. Applicant: Hoya Conbio, Inc..

Clearance details

Applicant: Hoya Conbio, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2006-11-08
Decision date: 2007-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twain Harte, CA, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.