ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES— 510(k) K072554

Substantially Equivalent

Sable Industries, Inc.

FDA 510(k) clearance K072554 for ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES, Substantially Equivalent on 2007-11-14. Applicant: Sable Industries, Inc..

Clearance details

Applicant: Sable Industries, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2007-09-10
Decision date: 2007-11-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Erie, CO, US

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.