Dual Core
FDA 510(k) K260805 · Vericom Co., Ltd.
510(k) numberK260805
Submission
- Device name
- Dual Core
- Applicant
- Vericom Co., Ltd.
Chuncheon-Si, KR - Received
- March 12, 2026
- Decision date
- May 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dual Core cleared by the FDA?
Dual Core (K260805) received a 510(k) decision of Substantially Equivalent on May 11, 2026, 60 days after the submission was received.
What is the product code of K260805?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.