PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES— 510(k) K083101

Substantially Equivalent

Sable Industries, Inc.

FDA 510(k) clearance K083101 for PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES, Substantially Equivalent on 2009-02-23. Applicant: Sable Industries, Inc..

Clearance details

Applicant: Sable Industries, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2008-10-20
Decision date: 2009-02-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Golden, 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.