DENTAL OR SURGICAL BUR— 510(k) K923883

Substantially Equivalent

Stratum Dental Technologies, Inc.

FDA 510(k) clearance K923883 for DENTAL OR SURGICAL BUR, Substantially Equivalent on 1993-07-27. Applicant: Stratum Dental Technologies, Inc..

Clearance details

Applicant: Stratum Dental Technologies, Inc.
Product code: Code EJL
Advisory panel: Dental
Date received: 1992-08-04
Decision date: 1993-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, 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.