Additively Manufactured Denture Resin— 510(k) K242884

Name: FDA 510(k) clearance K242884
Creator: U.S. Food and Drug Administration
Published: 2024-11-22

Substantially Equivalent

Aidite (Qinhuangdao) Technology Co., Ltd.

FDA 510(k) clearance K242884 for Additively Manufactured Denture Resin, Substantially Equivalent on 2024-11-22. Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2024-09-23
Decision date: 2024-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qinhuangdao, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

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K261802 — Glidewell Denture Base Resin2026-08-27
K261626 — UltraPrint Flexible Denture UV2026-08-13
K262681 — NanoCeram Resin2026-07-31
K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

More clearances from Aidite (Qinhuangdao) Technology Co., Ltd.

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K253036 — Light-curing Coloring Materials (ALCM)2026-04-06
K251415 — Additively Manufactured Aligner Resin2025-08-27
K250534 — Biomic Color Opaque2025-05-20
K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin2025-04-30
K250811 — Dental Zirconia Ceramic2025-04-11

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.