ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU— 510(k) K962543

Substantially Equivalent

Nsk Nakanishi, Inc.

FDA 510(k) clearance K962543 for ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU, Substantially Equivalent on 1996-09-11. Applicant: Nsk Nakanishi, Inc..

Clearance details

Applicant: Nsk Nakanishi, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 1996-06-28
Decision date: 1996-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tochigi-Ken, JP

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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.