SOFT DENTURE RELINE MATERIAL ELASTOLINE— 510(k) K925275

Substantially Equivalent

Great Lakes Orthodontics, Ltd.

FDA 510(k) clearance K925275 for SOFT DENTURE RELINE MATERIAL ELASTOLINE, Substantially Equivalent on 1993-01-11. Applicant: Great Lakes Orthodontics, Ltd..

Clearance details

Applicant: Great Lakes Orthodontics, Ltd.
Product code: Code EBI
Advisory panel: Dental
Date received: 1992-10-20
Decision date: 1993-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonawanda, NY, US

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Adverse events under product code EBI

product code EBI

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.