DIAMOND D HIGH IMPACT DENTURE ACRYLIC— 510(k) K032773

Name: FDA 510(k) clearance K032773
Creator: U.S. Food and Drug Administration
Published: 2003-09-23

Substantially Equivalent

Mycone Dental Supply Co., Inc.

FDA 510(k) clearance K032773 for DIAMOND D HIGH IMPACT DENTURE ACRYLIC, Substantially Equivalent on 2003-09-23. Applicant: Mycone Dental Supply Co., Inc.. Device class: 2.

Clearance details

Applicant: Mycone Dental Supply Co., Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2003-09-08
Decision date: 2003-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Cherry Hill, NJ, 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.