DIAMOND BURS-HANDPIECE— 510(k) K854691

Substantially Equivalent

Almore Intl., Inc.

FDA 510(k) clearance K854691 for DIAMOND BURS-HANDPIECE, Substantially Equivalent on 1986-03-25. Applicant: Almore Intl., Inc..

Clearance details

Applicant: Almore Intl., Inc.
Product code: Code EJL
Advisory panel: Dental
Date received: 1985-11-21
Decision date: 1986-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

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Adverse events under product code EJL

product code EJL

Other: 1
Total: 1

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.