Denture Base— 510(k) K260376
Substantially EquivalentShandong Huge Dental Material Corporation
FDA 510(k) clearance K260376 for Denture Base, Substantially Equivalent on 2026-05-06. Applicant: Shandong Huge Dental Material Corporation. Device class: 2.
Summary
Shandong Huge Dental Material filed the Denture Base under EBI, denture relining, repairing and rebasing resins. The device name is generic.
Class II, 21 CFR 872.3760. Dental is both the classification panel and the review panel, and it was a Traditional 510(k).
Huge Dental filed from Rizhao City, China. The decision came 90 calendar days after receipt (February 5 to May 6, 2026).
Clearance details
- Applicant
- Shandong Huge Dental Material Corporation
- Product code
- Product code EBI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rizhao City, CN
Recent devices under product code EBI
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view allAdverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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