DD medical polymers (PMMA)— 510(k) K230410

Name: FDA 510(k) clearance K230410
Creator: U.S. Food and Drug Administration
Published: 2023-06-23

Substantially Equivalent

Dental Direkt GmbH

FDA 510(k) clearance K230410 for DD medical polymers (PMMA), Substantially Equivalent on 2023-06-23. Applicant: Dental Direkt GmbH. Device class: 2.

Clearance details

Applicant: Dental Direkt GmbH
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2023-02-15
Decision date: 2023-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Spenge, DE

Download summary PDF View on FDA.gov ↗

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K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

More clearances from Dental Direkt GmbH

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K241579 — DD Hybridlayer (multicolored zirconia)2024-09-06
K230218 — DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)2023-04-25
K191111 — DD Solid Connect® CAD/CAM Abutments2023-01-11
K193588 — DD Contrast2020-04-16
K183569 — DD cube ONE ML2019-02-14

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.