LUTEMOLL (BIOPLAST)— 510(k) K871038

Name: FDA 510(k) clearance K871038
Creator: U.S. Food and Drug Administration
Published: 1987-05-19

Substantially Equivalent

B. L. Dental Co.

FDA 510(k) clearance K871038 for LUTEMOLL (BIOPLAST), Substantially Equivalent on 1987-05-19. Applicant: B. L. Dental Co.. Device class: 2.

Clearance details

Applicant: B. L. Dental Co.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 1987-03-17
Decision date: 1987-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond Hill, NY, US

Download summary PDF View on FDA.gov ↗

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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.