SHORTSTOP DISPOSABLE PROPHY ANGLE— 510(k) K955654

Substantially Equivalent

Spintech, Inc.

FDA 510(k) clearance K955654 for SHORTSTOP DISPOSABLE PROPHY ANGLE, Substantially Equivalent on 1996-02-08. Applicant: Spintech, Inc..

Clearance details

Applicant: Spintech, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 1995-12-12
Decision date: 1996-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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.